Teleflex Medical de Tecate, S. de R.L de C.V.

FDA Device Registration & Listing · TECATE Baja California, MX · Registration 3003898360

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003898360
FEI Number
3003898360
Entity Name
Teleflex Medical de Tecate, S. de R.L de C.V.
City/State/Country
TECATE Baja California, MX
Establishment Address
(A Teleflex Medical Company), Prolongacion Mision Eusebio Kino No. 1316,Rancho El Descanso, TECATE Baja California C.P. 21478, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Teleflex (Owner Number: 9062981)
Owner / Operator Contact Address
3015 Carrington Mill Blvd., Morrisville, NC 27560, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

QuikClot Control+ McKenzie V Clips RS MULTIPLE ATOMIZER AND TIP ENT NON-VENTILATORY NEBULIZER MAD Nasal Mist MAD Nasal VaxINator Mucosal Atomization Device (MAD) NON=VENTILATORY MEDICINAL NEBULIZE AVA NEB NEBULIZER TIP ENT MULTIPLE ATOMIZERS ATOMIZER Ringer Perfusion Balloon Catheter Langston dual lumen catheter MANTA Vascular Closure Device MANTA Depth Locator HEMOLOK Ligating Clips & Cartridges TrapLiner catheter. Model Numbers: 5566-TrapLiner catheter 6F, 5567-TrapLiner catheter 7F, 5568-TrapLiner catheter 8F QuikClot Radial Pleur-evac Suction catheter with saline KMEDIC WECK Pilling HUMID-VENT HEAT AND MO MULTIPLE HEAT HUMID-FLO MOISTURE ARTIFICIAL NOSE CONDENSER HEAT AND MOISTURE VARIOUS TYPES OF HEAT AND MOISTURE EXCHANGERS Autofuser Teleflex ISIS HVT Horizon Sher-I-Bronch Endobronchial Tube GuideLiner Coast Catheter M5270 GuideLiner Coast,M5271 GuideLiner Coast, M5272 GuideLiner Coast,M5273 GuideLiner Coast Directable Cholangiography catheter ADAPT LAPAROSCOPIC TAUT DA VINCI Weck Vista Standard Staple-Line Reinforcement HEMOLOK SMX Ligating Clip Polymer HEMOLOCK Hemolok RuschFlex, armoured Tracheal tube RuschFlex, armoured tracheal tube, cuffed Sheridan Spiral-Flex Reinforced Endotracheal Tube PILLING HEMOLOK Clip Appliers. Horizon, Hem-O-Clip Traditional, Hem-O-Clip Plus, Hem-O-Lok, VSI Micro-Introducer Kit CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS PERITONEAL CATHETER GERY TAUT WECK VISTA INTRADUCER PERITONEAL#GENERAL AND PLASTIC SUR MULTIPLE PERITONEAL CATHETERS Taut Bandit guidewire. Modell numbers:7444 Bandit Guidewire 200cm5Pk and 7445 Bandit Guidewire 300cm5PK EquipLite Standard Laryngoscope Blades and Handles Rusch GreenLite Shucman 2 DispoLED DispoGrip GreenSpec EquipLED TruLED TruLite Secure GreenLED Fiber Optic Laryngoscope Blades and Handles Dolphin SnapLight Rusch Polaris Accumed Wrist Splint. Model Numbers 3565-Accumed PWPS and 3560-Accumed II, Flat MANTA Vascular Closure Device HEMOCLIP AUTOMATIC CLIPS MEDIUM Hem-o-lok Plus PurplePlus Weck Teleflex ISIS HVT LMA ProSeal LMA Fastrach (SU) LMA Unique (Silicone Cuff) LMA Supreme LMA Flexible (SU) Oropharyngeal Guedel Tube Black LMA Cuff-Deflator LMA Unique (Silicone Cuff) Cuff Pilot LMA ProSeal Introducer LMA Unique Evo Cuff Pilot LMA Protector Cuff Pilot LMA Fastrach LMA Flexible LMA ProSeal Cuff Deflator LMA Protector LMA Unique Evo LMA Classic Excel LMA Unique LMA Gastro Cuff Pilot LMA Unique PreCurved LMA Classic LMA Flexible PreCurved LMA Unique PreCurved Cuff Pilot LMA NovaPlus LMA Supreme Plus Pack LMA Flexible PreCurved Cuff Pilot MADgic Airway LMA Fastrach Stabiliser Rod LMA Unique (S) Cuff Pilot LMA Flexible (S) LMA Unique (S) LMA Flexible (S) Cuff Pilot Cath-Guide Guedel Airway Airway Lifesaver Kit Ovassapian Airway Dual Channel Airway Rusch Breathing Bag Hudson Neoprene Pecan Breathing Bag Rusch Pecan Breathing Bag Hudson Anesthesia Circuit Hudson RCI Test Lung Hudson Anesthesia Breathing Bags Hudson Anesthesia Circuit Assessories Rusch Anesthesia Breathing Bags ADAPT UNIVERSAL LAPAROSCOPIC PORT, TAUT WECKVISTA WECK KMEDIC bipolar electosurgical forcep PILLING Y Connector Elbow Connector M Connector Connector Sher-I-Swiv Double Swivel Connector CPRAM Respiratory Assist Device Hudson RCI Adaptors and Connectors Rusch Connector Oxygenator Rusch Connector Trach Tee Fitting Hudson RCI Tubing Hudson RCI Sensor Tee Rusch Connector with Barbed Elbow Gibeck RCI Softech Bi-Flo Cannula Hudson RCI Softech Bi-Flo Cannula Ligation Clips MADgic Sheridan Soft-Tip Intubating Stylet Sher-I-Swiv/FO Double Swivel Connector Sheridan Sher-I-Slip Intubating Stylet Rusch Endotracheal Tube Stylet UroLift System UL400 Sher-I-Bronch Endobronchial Tube Tracheal Tube QuikClot Interventional Arrow VPS G4 System HEMOLOK HEM O LOCK LIGATION CLIPS RUSCH AGT PVC PREFORM NASAL VPS Rhythm DLX Device with TipTracker Technology NaviCurve Stylet TipTracker Stylet PILLING Sheridan Spiral-Flex Reinforced Endotracheal Tube HUMID-VENT FILTER SMALL HUMID-VENT FILTER COMPACT WECK Raney Scalp Clips Epidural Catheter Weck, Horizon, Hemoclip Traditional, Hemoclip Plus HORIZON WECK HEMOCLIP R350 guidewire Model Number: 7390 R350 V2 Guidewire, 5pk Weck®, Hem-o-lok®, Auto Endo5® Teleflex ADAPT LAPAROSCOPIC TAUT Weck Vista VPS Rhythm Device with TipTracker Technology Hudson Sampling Lines and Filters Gas Sampling Lines Multiple Ventilator T Corr A Tube Smooth Flo Corr A Tube II Corr A Flex Rusch Sampling Lines, Rusch Anesthesia Circuit Accessories Catheter Mount Rusch Corrugated Tubing Venti-Comp Gibeck RCI SOFTFLEX Hudson Anesthesia Circuit Assessories CONMED HEMOLOK ENDO5 SuperCross FT (Model numbers:5340 SuperCross 014FT, 130cm and 5341 SuperCross 014 FT, 150cm) HEMOCLIP Ligating Clip Med/Lrg Arrow VPS System, VPS Bedside procedure Kit and VPS Stylet component Warrior guidewire Model Numbers: 7389 Warrior Guidewire 300CM and 7388 Warrior Guidewire 200CM SHERIDAN LITA Cuffed Endotracheal Tube Sheridan Lar-A-Ject Reinforced Laryngectomy Tube PILLING Teleflex SIMS Anesthesia Breathing Circuit Hudson Sampling lines and Filters Rusch Anesthesia Circuit Accessories Rusch Pediatric Rebreathing Circle Systems ISO-GARD Drain Circuit Technology Hudson RCI Conventional Breathing Circuits Rusch Face Mask Plug Rusch CPRAM Anesthesia Circuits Hudson CPRAM Anesthesia Circuits Rusch sampling lines and filters Anesthesia Circuit Sheridan Flex-C-Pap Rusch Adult Anesthesia circuit Rusch Disposable Adult Rebreathing Circle Systems Rusch RCI Conventional Breathing Circuits Hudson Anesthesia Circuit Accessories Rusch EPDM FLEX CONNECTOR Rusch Anesthesia Circuit Rusch Adult Rebreathing Circle Systems Hudson Disposable Adult Rebreathing Circle Systems Hudson Pediatric Rebreathing Circle Systems Hudson RCI Rusch RCI Hudson Non-Rebreathing Single Limb Systems Hudson Adult Rebreathing Circle Systems Hudson Anesthesia Circuit Rusch Non-Rebreathing Single Limb Systems Pronto V4 ISO-Gard Mask Horizon Ligating Clips, Titanium KMEDIC WECK Suction Tube PILLING WECK PILLING LMA Fastrach ETT QuikClot Combat Gauze, QuikClot Combat Gauze TraumaPad QuikClot Bleeding Control Dressing QuickClot EMS ADAPT LAPAROSCOPIC WECK VISTA Bite Gard Hudson Bite-Guard Bite-Gard Oral Bite Block Teleflex SHER-I-BRONCH ACCESSORY PACK VISISTAT STAPLER QuikClot Interventional Multiple Tracheal Tubes W/O Connect Arrow VPS stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS PILLING KMEDIC PLASTIC SURGERY SURGICAL HOOKS SURGICAL HOOK FOR ENT MULTIIPLE SHERIDAN DIFFERENTIAL VENT. TUBES MULTIPLE TRACHEAL-BRONCHIAL LASER RESISTANT TRACH TUBE TAUT INSUFFLATION NEEDLE TAUT WECK VISTA Stapler, Skin Rusch Easytube RUSCH Double lumen Bronchial tube, White RUSCH Double lumen Bronchial tube, Carlens VSI Micro-Introducer™ Kit UroLift 2 System WECK VISTA Taut Weck Weck, Hem-o-lok, Hemolok UroLift Advanced Tissue Control (ATC) System SHERIDAN LARYNGECTOMY MULTIPLE LARYNGECTOMY TUBES Twin-Pass Dual Access Catheter Taut Aquatherm Sprotte Needle SUPERCROSS WECK VISTA Teleflex External Catheter Condom Catheter Rusch Male Exeternal Catheter WECK HEMOCLIP PILLING WECK M-20 DISPOSABLE AUTOMA SHERIDAN STAT-MED Cuffed Endotracheal Tube End Tidal CO2 Tube UroLift 2 ATC Advanced Tissue Control System, UL2 ATC Rusch Single Lumen Bronchial Tube

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
POD Temporary, Internal Use Hemostatic General, Plastic Surgery Class 2 878.4454 2025-08-07
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2006-05-15
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2025-08-14
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-07-18
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2023-10-23
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-01-08
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-07-24
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 1995-10-05
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2007-06-26
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2005-07-12
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2015-09-11
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2009-11-19
DSS Clip, Vascular Cardiovascular Class 2 870.3250 2011-04-07
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Anesthesiology Class 2 868.5740 2006-05-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-03-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-03-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-05-31
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2023-11-29
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2014-05-08
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2006-05-16
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2011-11-30
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 1995-09-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-11-03
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2016-02-05
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2016-02-05
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2007-05-31
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2013-04-17
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2013-04-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-05-29
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2005-03-03
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2025-02-21
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2024-09-27
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2011-04-07
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-07-07
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2015-08-19
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2001-06-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-06-20
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2005-07-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-09-02
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2010-02-22
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2006-05-16
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2006-05-15
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2010-10-21
CCT Applicator (Laryngo-Tracheal), Topical Anesthesia Anesthesiology Class 2 868.5170 2016-09-15
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2001-05-19
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2020-11-24
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Anesthesiology Class 2 868.5740 2012-03-28
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2006-05-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-09-11
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-07-24
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-03-12
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2011-09-08
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2006-05-16
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2022-08-29
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2011-11-30
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2012-02-01
HBO Clip, Scalp Neurology Class 2 882.4150 2008-03-11
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2008-04-28
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2015-09-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-05-29
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2023-05-05
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2023-05-05
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2006-05-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-05-31
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-09-07
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2006-07-11
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-05-09
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-03-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-05-29
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2011-11-30
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2006-05-16
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2005-07-12
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2025-08-22
CBN Apparatus, Gas-Scavenging Anesthesiology Class 2 868.5430 2015-04-09
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-08-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2001-05-10
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2013-05-20
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-07-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-01-23
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2011-08-24
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2006-05-16
OFR Tracheobronchial Suction Catheter Kit Anesthesiology Class 1 868.6810 2011-12-16
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2005-06-16
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-07-24
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2006-05-16
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2015-11-04
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1998-06-23
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Anesthesiology Class 2 868.5740 2006-05-15
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-05-31
QQS Stapler, Skin General Hospital Class 1 878.4740 2022-04-13
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-03-11
BTS Tube, Bronchial (W/Wo Connector) Anesthesiology Class 2 868.5720 2007-05-01
OFC Catheter Introducer Kit Cardiovascular Class 2 870.1340 2025-11-20
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2023-05-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-06-04
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-06-09
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2023-07-19
KAC Tube, Laryngectomy Ear, Nose, Throat Class 1 874.4420 2006-05-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-04-05
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2013-04-17
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2006-05-15
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2013-09-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-09-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2011-10-24
NNY Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2011-03-14
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2009-09-15
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2011-12-01
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2023-10-27
BTS Tube, Bronchial (W/Wo Connector) Anesthesiology Class 2 868.5720 2008-03-11

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

Teleflex
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

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3013515223 T.K. India Pvt. Ltd. Chandigarh, IN
3004365956 Teleflex Medical de Mexico, S. de R.L. de C.V. NUEVO LAREDO Tamaulipas, MX
3010041511 Teleflex LLC (NADC) Olive Branch, MS, US
3007134520 TELEFLEX MEDICAL ATHLONE Westmeath, IE
8040412 Teleflex Medical Sdn. Bhd. KAMUNTING Perak, MY

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Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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3011137372 Teleflex Medical LLC Morrisville, NC, US
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1219313 CARWILD CORP. NEW LONDON, CT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003898360. Last updated year: 2026. Please use registration number 3003898360 when referencing this establishment in official correspondence.
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