Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680794

FEI Number

3003737899

Entity Name

Arrow Internacional de Chihuahua S.A. de C.V.

City/State/Country

CHIHUAHUA, MX

Establishment Address

Ave. Washington 3701, Interior Circuito Industrial, Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana, CHIHUAHUA CP 31200, MX

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Arrow International LLC (subsidiary of Teleflex Incorporated (Owner Number: 2518433)

Owner / Operator Contact Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112896

PMA Number

N/A

All Registered Proprietary Names

Arrow® Thermodilution Catheters Infusion Port Thermodilution Arrow(TM) Endurance(TM) Extended Dwell Peripheral Catheter System Intravascular catheter securement Arrow® Epidural Needle Arrow Epidural Anesthesia Kit Arrow Access Tray Arrow® Continuous Epidural Needle Arrow Single Shot Epidural Anesthesia Kit Single Shot Epidural Anesthesia Kit FlexTip Plus & Accessories Arrow UserGard(R) Needle-Free Injection Hub USER-GARD NEEDLESS INJECTION HUB Vessel catheterization Kit/Set Arrow Select Kits Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus® Epidural Catheterization Kit for Caudal Placement SnapLock Clamp Fastener Arrow® SnapLock Catheter/Syringe Adapter FlexTip Plus® Epidural Catheterization Kit FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement The INT STOPPER Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter M-L CVC w/BlueFlex Tip PICC Drape surgical HEIMLICH VALVE COMMERCIAL Walrus embolectomy catheter Embolectomy Catheter Arrow FlexBlock Continous Peripheral Nerve Block Kits RediGuard® Intra-Aortic Balloon System RediGuard® Intra-Aortic Balloon Catheter Arrow Jugular Puncture Kit Single Lumen CVCs Cannon II Plus Arrow PSI PERCUTANEOUS SHEATH INTRODUCER Mandrel Guidewires Surgical Apparel Gown Arrowg+ard Blue Advance PICC pre-loaded with ARROW® VPS® Stylet Arrowg+ard Blue Advance PICC Forceps Walrus Spring Wire Guides Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter ARROW® FlexBlock Continuous Peripheral Nerve Block Sets ARROW® FlexBlock Continuous Peripheral Nerve Block Kits ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter APLICARE ALCOHOL PREP PAD ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN Catheter Clamp with Fastener CathGuard STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK Arrow Seldinger Arterial Catheterization Device ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS NextStep Retrograde Edge Cannon II Plus Drape surgical Arrow VPS G4 Staple Anchoring Device 0.9% SODIUM CHLORIDE FLISH SYRINGE ACCESS TRAY SWG Elcam Stopcock Large Bore Multi-Lumen CVCs Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter Arrow Non-Absorbable Silk Suture Silk Suture BD Eclipse Hypodermic Needle Drape, Surgical MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS 3M BRAND EAR LOOP FACE MASK, 2000F Stopcock Transseptal Super ArrowFlex PSI Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set Arrow(TM) Endurance(TM) Extended Dwell Peripheral Catheter System Radial Artery Catheter Arterial Access Tray Art./Venous Cath Set Arterial Catheter Kit RA Cath Kit Arterial Cath Kit Arterial Catheterization Kit Arterial Line Kit CVC Kit Spring Wire Guide Component Micro Introducer Set NITRILE POWDER-FREE EXAMINATION GLOVES Arrow Endurance Extended Dwell Peripheral Catheter System MIDLINE CATHETERS Introcan@S afetyTMIV Catheter Arrowg+ard Blue Advance Midline GAUZE PADS PICC ACCESS TRAY Surgical apparel glove Needle Needle Safety Glide Arrowg+ard Blue Advance PICC pre-loaded with ARROW® VPS® Stylet Spring Wire Guide Arrow OnControl Powered Bone Access System HEMOSTAT SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES Arrow SharpsAwayII¿ Locking Disposal Cup SharpsAway Needle Disposal Cups TOURNIQUET COMMERCIAL Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter ARROWg+ard Blue Plus Multi-Lumen CVC Kit ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit ARROWg+ard Blue Plus Two-Lumen CVC Kit ARROWg+ard Blue Plus Two-Lumen CVC Super Kit ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit ARROWg+ard Blue Plus Multi-Lumen CVC Set ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit AGB+ Two-Lumen CVC Kit AGB+ Multi-Lumen CVC Kit ARROWg+ard Blue Plus Quad-Lumen CVC Set ARROWg+ard Blue Plus Quad-Lumen CVC AGB+ Quad Lumen CVC Kit ARROWg+ard Blue Plus Two-Lumen CVC Set ARROWg+ard Blue Plus Two-Lumen CVC Ag+ Blue Plus ML CVCs Catheter Hemodialysis Balloon Thermodilution Catheter Arrow® Thermodilution Catheters Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter ARROWg+ard CVCs Drape surgical Continuous Epidural Anesthesia Kits 3-WAY STOPCOCK S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS EF-05510N: FILTER COMPONENT NRFit GVS Sprotte BLOOD COLLECTION TUBE, LAVENDER Arrow Central Venous Catheterization Kit Multi-Lumen CVC Hemodialysis (Acute) Products Marked Spring-Wire Guide with Arrow Advancer Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter Arrow Central Venous Catheterization Kit Puncture Kit, Disposable Vein Arrowg+ard Blue Advance JACC BD ECLIPSE HYPODERMIC NEEDLE ANGIOCATH & INSYTE AUTOGUARD CATHETERS Ultrasound Gel 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS CG+ Arrow PICC Powered by Arrow VPS Stylet Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature Arrow TheraCath® Epidural Catheter Arrow Epidural Catheterization Kit with TheraCath® Catheter KDL SYRINGES AND NEEDLE DALE BENDABLE ARMBOARD N/A Electrode, Electrocardigraph ARROWg+ard Hemodialysis Catheters Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter Arrow® TransRadial Artery Access Kit Arrow® TransRadial Arterial Access Device Pneumothorax Set Praxiject 0.9% NaCl Arrow Stiffening Stylet ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC) SUR Betha Sheet Holder Multiple General Use Bandage, Liquid, Skin Protectant tunneling instrument Drape, Surgical Catheter Hemodialysis Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device ARROWg+ard 2-L Access (MAC) Super Arrow-Flex® Percutaneous Sheath Introducer Set Super ArrowFlex PSIs RediGuard IABs ARROW INTRA-AORTIC BALL LBCVC KIT ACCESS TRAY CVC/PSI KIT MULTILUMEN CVC KIT MULTILUMEN PI CVC KIT PI CATHETER CVC KIT CVC SET PI CVC KIT PI CVC KIT AGB+ Internal Jugular Arrow® Wedge Pressure Catheter Kit Arrow® Thermodilution Catheter Kit Arrow® Berman Catheter Kit Arrow VPS AGBA PICC Radiopaque polyurethane multi-lumen indwelling catheter with heparing coating Guide Wire - Lake Region Extension Tubing High Flow Fluid Administration Set Foosin Silk Suture SCALPEL COMMERCIAL Hands-off Thermodilution Catheters Arrow Echogenic Introducer Needle Echogenic Introducer Needle Cannon II Plus Replacement Hub Set NextStep Retrograde Replacement Hub Set Drape NextStep Retrograde (femoral lengths) BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY Arrow® Sheath Adapter with Cath-Gard® Catheter Contamination Shield Sheath Adapter Multiple Ag+ Super ArrowFlex PSIs Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath Pronto LP Extraction Catheter Clamp PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke Pleura-Seal® Thoracentesis Set Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit Pneumothorax Set 3M Tegaderm +Pad Film Dressing with Non-Adherent Pad Sterile Arrowg+ard Blue Advance PICC pre-loaded with Arrow® VPS Precision Stylet INTROCAN SAFETY IV CATHETER INTRODUCER & INJECTION NEEDLES Pressure Injectable PICC Multiple PICC v2 Arrow PICC Metz Offset Scissors StimuCath (19 Ga) STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES INTERLINK(TM) INJECTION SITE Transduction probe BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE ARROW® OnControl® Bone Lesion Biopsy System Mandrel Guidewire TERUMO® SURFLO®0 IX. Catheter .9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter, 14 Fr 2-L Hemodialysis Catheters You-Bend Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter NEW HYDROPHILIC COATING FOR WIRE GUIDES Liver Biopsy Kit ACCESS TRAY cutter surgical Blade Cutter Drape, Surgical AM/AT PICC PICC with Chlorag+ard Technology ARROWg+ard Evolution Antimicrobial Pressure Injectable PICC CG+ PICC instrument forceps Becton Dickinson Syringe Specimen Container Tearaway Introducer Sheath, MicroSlide Tearaway Introducer VANISHPOINT SYRINGE Arrow Berman Catheter, Arrow Berman Angiographic Catheter, Wedge Pressure Catheters and Reverse Berman Catheters LOR Syringe Predicate III Guidewire OnControl Bone Marrow Biopsy System SCALPEL COMMERCIAL Drape, Surgical Filter Needle Arrow Catheter Clamp for 5, 6, 7 and 8 Fr. Catheters Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography Arrow-Johans ECG Adapter Razor commercial Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter Ag+ Quad Lumen CVCs LARGE BORE SPLITTABLE INTRODUCER KIT Arrow Endurance Extended Dwell Peripheral Catherer System N/A EZ-IO Single-Use Procedure Trays wrap, sterilzation Arrow Quickflash Arterial Catheterization Device Percutaneous Sheath Introducers Arrow Twin-Cath(R) 20/22 Multiple-Lumen Peripheral Catheter TwinCath Intravenous Catheters Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter Arrow® Access Tray Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter Arrow Epidural Catheterization Kit with TheraCath® Arrow Epidural Anesthesia Kit Arrow Epidural Catheterization Kit with TheraCath® Catheter Epidural Catheterization Kit Arrow Access Tray Arrow Single Shot Epidural Anesthesia Kit Arrow Epidural Catheterization Kit Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter Arrow Epidural Needle Arrow Epidural Needle Kit Drape, surgical Drape, Surgical Cannon Hemodialysis Catheter Intra-Aortic Balloon (IAB) Catheter AutoCAT®2 Intra-Aortic Balloon Pump (IABP) Fiber Optic System (FOS) FiberOptix® IAB Catheter, FIBEROPTIX® Intra-Aortic Balloon Catheter, Ultra 8® AutoCAT®2 Series RediGuard® Intra-Aortic Balloon Catheter AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP) Emergency Infusion Device Trauma Kit Arrow® Emergency Infusion Device - EID¿ Arrow Peritoneal Lavage Catheterization Kit ARROW PERITONEAL LAVAGE KIT Arrow Simplicity Micro-Introducer Set none Arrow-Clarke Pleura-Seal® Thoracentesis Set ARROW THORACENTESIS KIT Arrow-Clarke Pleura-Seal Thoracentesis Kit VectorFlow Retrograde Replacement Hub Set VectorFlow Retrograde Chronic Hemodialysis Catheter VectorFlow Antegrade Chronic Hemodialysis Catheter Arrow-Clark VectorFlow Retrograde Hemodialysis Catheterization Set Arrow-Clark VectorFlow Retrograde Replacement Hub Set Arrow-Clark VectorFlow Antegrade Hemodialysis Catheterization Set Drape, Surgical APLICARE THREE ALCOHOL SWABSTICKS EXT. LINE SLIDE CLAMP SLIC PERITONEAL LAVAGE CATH KIT NarrowFlex® Intra-Aortic Balloon (IAB) System NarrowFlex® Intra-Aortic Balloon (IAB) Catheter Drape, surgical VPS RHYTHM PI JACC KIT PI AGBA PICC KIT AGBA PICC PICC SET PI PICC NaviCurve PI PICC KIT PI CG+ PICC SET AGBA PICC NaviCurve PICC KIT AGBA PI JACC KIT ACCESS TRAY AGBA PICC KIT TIPTRACKER STYLET ACCESSORY PACK AGBA PICC/DELTA PI PICC AM PICC AGBA PI PICC KIT Catheter Hemodialysis Cannon Hemodialysis Catheter VectorFlow Retrograde Replacement Hub Set AHDC AGB KIT NextStep Antegrade Arrow-Clark VectorFlow Antegrade Hemodialysis Catheterization Set VectorFlow Retrograde Chronic Hemodialysis Catheter HEMODIALYSIS KIT AHDC AGB U-BEND KIT HEMODIALYSIS SET AHDC AGB CURVED KIT Cannon II Plus; Edge Cannon II Plus Replacement Hub Set NextStep Retrograde Replacement Hub Set NextStep Retrograde Arrow-Clark VectorFlow Retrograde Hemodialysis Catheterization Set Arrow-Clark VectorFlow Retrograde Replacement Hub Set NextStep Retrograde (femoral lengths) VectorFlow Antegrade Chronic Hemodialysis Catheter AHDC KIT LBCVC AGB KIT Abdominal Paracentesis Kit Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit Arrow "No Leak" Sheath Adapter with Side Port NextStep Antegrade - Arrow PICC Powered by Arrow VPS Stylet LBCVC KIT MULTILUMEN PI CVC KIT PI CG+ PICC SET MULTI LUMEN CVC KIT CVC KIT AM/AT PI MIDLINE PI CVC SET PI AGBA PICC KIT ACCESS KIT ARROW(R) VPS(R) ACCESS KIT PICC KIT AGBA PI MIDLINE PREP TRAY AGBA PICC CVC SET PI PICC QUAD LUMEN PI CVC KIT PICC SET PI MIDLINE PI CVC KIT CG+ PICC SET VESSEL CATH KIT INTRAVENOUS SET PREP KIT AM PICC SET PI CATHETER ACCESS TRAY PI MULTI LUMEN CVC AGBA PI PICC KIT PI JACC KIT MIDLINE CATHETER KIT Hypodermic Needle and Syringe Sponge Arrowg+ard Blue Advance PICC pre-loaded with Arrow® TipTracker Stylet Arrowg+ard Blue Advance PICC with 130 cm Hydrophilic-Coated Nitinol Guidewire Arrowg+ard Blue Advance PICC pre-loaded with Arrow® VPS Precision Stylet Arrowg+ard Blue Advance PICC Arrowg+ard Blue Advance PICC Kit Arrowg+ard Blue Advance PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-03-31
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-01-22
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	1998-03-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-05-31
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2015-07-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1998-02-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-11-04
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-12-04
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2019-05-20
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2008-02-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-03-01
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-07-08
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2016-03-04
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-02-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-04-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-04-28
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-09-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-09-16
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-09-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-03-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-12
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2018-05-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-19
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2009-12-17
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-02-29
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-02-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-02-29
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-02-29
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-02-29
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-02-29
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-02-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-07-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-03-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2012-04-18
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2010-02-09
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2010-02-09
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-04-28
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2008-06-03
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2018-06-13
PXB	Percutaneous Introducer Kit	General Hospital	Class 2	880.5570	2026-01-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-11-17
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2011-03-11
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-13
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-02-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-02-06
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-04-25
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-08-04
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-11-04
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-04-25
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2010-11-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-01-28
OFB	Catheter Guide Wire Kit	Cardiovascular	Class 2	870.1330	2026-01-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-12-09
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-03-31
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-01-31
PND	Midline Catheter	General Hospital	Class 2	880.5200	2016-10-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-09-17
PXK	Vascular Access Port Kit	General Hospital	Class 2	880.5965	2026-01-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2016-02-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-11-17
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2015-07-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-02-25
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-10
POZ	Biopsy Needle Kit	Gastroenterology, Urology	Class 2	876.1075	2025-12-10
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2018-03-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-01-11
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-01-11
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-11
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-01-11
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-01-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-14
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2016-02-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-03-02
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-15
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2016-03-18
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-05-19
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2009-07-27
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2016-05-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2007-12-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-12-16
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-02-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-02
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-02-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-01-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-11-01
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-07-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-07-13
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2016-03-03
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-11-12
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2020-11-13
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-02-16
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2007-12-13
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2018-11-01
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2015-08-19
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2022-09-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2012-08-28
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-12-17
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2016-05-27
MZY	Graft, Vascular, Stainless Steel Tunneler	Cardiovascular	Class 2	870.3450	2016-01-29
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2011-04-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-02-05
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2026-01-15
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2010-11-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-03-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-12-22
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2008-12-22
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2008-12-22
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-12-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-09-04
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-11-15
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2014-02-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2008-02-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-03-04
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-01-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-03-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-02-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2025-09-24
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-05-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-03-26
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2025-12-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2015-11-05
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2016-02-05
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-02-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-02-11
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1995-02-02
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-12-17
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-02-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-02-29
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-03-30
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2019-07-24
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-06-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-02-10
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2018-05-31
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-06-04
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-12-13
POR	Parenteral Administration Kit	General Hospital	Class 2	880.5440	2026-01-15
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-12-17
SEL	Securement Wound Dressing For Reduction Of Infection	Unknown	Class U	N/A	2015-12-04
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-04-04
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-11-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2015-06-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-11-19
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2018-11-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2021-01-06
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-06-04
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-04-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-06-03
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-06-03
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-09-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-07-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-13
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2016-01-21
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2007-12-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-13
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-01-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-02-10
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-02-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-11-25
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2018-09-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-24
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-04-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-02-13
OFK	Percutaneous Atrial Catheter Kit	Cardiovascular	Class 2	870.1250	2026-01-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2010-11-19
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-13
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-02-15
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2001-07-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-13
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2006-06-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-02-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-02-13
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2006-06-19
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2008-07-23
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2014-07-16
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-07-16
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2016-06-24
PYG	Suction Catheter Kit	General, Plastic Surgery	Class 1	878.4200	2026-01-15
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-12-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-01-21
PWR	Catheter Repair Kit	General Hospital	Class 2	880.5970	2026-01-15
PPO	Multi-Lumen Hemodialysis Catheterization Kit	Gastroenterology, Urology	Class 2	876.5540	2025-12-18
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-03-22
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-03-22
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2008-02-15
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2012-04-18
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2026-01-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-02-04
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-02-04
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2016-06-30
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2012-06-07

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Arrow International LLC (subsidiary of Teleflex Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010532612	Arrow International, LLC (subsidiary of Teleflex, Incorporated)	Chelmsford, MA, US
3006425876	Arrow International C.R. a.s.	ZDAR NAD SAZAVOU Vysocina, CZ
3013162291	Arrow International LLC (subsidiary of Teleflex Incorporated)	Morrisville, NC, US
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
1000563940	Arrow International CR, a.s.	Hradec Kralove, CZ

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833836	Instrumentation Laboratory CO	IL HEPARINIZED FLOW DIRECTED THERMAL	1984-02-04
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
2648045	EDWARDS LIFESCIENCES TECHNOLOGY SARL	ANASCO, PR, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
9615817	CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG	HAINA San Cristobal, DO
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680794. Last updated year: 2026. Please use registration number 9680794 when referencing this establishment in official correspondence.