Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000393132

FEI Number

1000393132

Entity Name

COOK INCORPORATED

City/State/Country

ELLETTSVILLE, IN, US

Establishment Address

6300 N. MATTHEWS DR., ELLETTSVILLE, IN 47429, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COOK, INC. (Owner Number: 1820334)

Owner / Operator Contact Address

750 DANIELS WAY, Bloomington, IN 47404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flexipet, Adjustable Handle Set Replacement O-Ring Set Use With K-MPH-1000 Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating Dual Lumen Ureteral Access Catheter Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating Flexi-Tip® Dual Lumen Ureteral Access Catheter CRAMER ERCP CATHETER GLO-TIP ERCP CATHETER GLO-TIP II DOUBLE LUMEN ERCP CATHETER HUIBREGTSE-KATON ERCP CATHETER CLASSIC ERCP CATHETER HABER RAMP CATHETER FUSION GLO-TIP ERCP CATHETER GLO-TIP II DOUBLE LUMEN ANGLED ERCP CATHETER Surgisis and Surgisis ES 1,4 Layer Tissue Graft Entuit Secure Gastrointestinal Suture Anchor Set Entuit Secure Adjustable Gastrointestinal Suture Anchor Set Flexor Ureteral Access Sheath with AQ Hydrophilic Coating Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating Non-Toxic Syringe Vacuum Syringe Taylor Gel Adapter Biodesign Otologic Butterfly Graft Biodesign Hernia Graft Acusnare Polypectomy Snare Needle's Eye Snare Retrieval Set - 54cm Biodesign Additae Hiatal Hernia Graft CorMatrix Cor Patch Retracta Detachable Embolization Coil Soft-Pass Coaxial Insemination Catheter Shepard Intrauterine Insemination Catheter Insemi-Cath Ultrathane Endoureterotomy Stent Set Liver Access and Biopsy Needle Set Liver Access and Biopsy Needle Cook-Swartz Doppler Flow Probe Standard Cuff Cook-Swartz Doppler Flow Probe Long Cuff Safety Wire Guide Introducer Tri-Ex Extraction Balloon with Multiple Sizing Williams Cystoscopic Injection Needle ENT/Sinonasal Soehendra Biliary Dilation Catheter Cotton Graduated Biliary Dilation Catheter Acusnare Polypectomy Snare Acusnare Polypectomy Snare Soft FUSION CYTOLOGY BRUSH CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH Flexor, Shuttle - SL Introducer with Tuohy-Borst Sidearm Flexor, Tuohy-Borst Side-Arm Introducer Shuttle,-SL Zimmon Needle Knife Papillotome SureTome SW Sphincterotome with DomeTip Fusion QuattroExtraction Balloon CATHETER ACCESSORIES Liberator Beacon Tip Locking Stylet Stylet Wires Advance, 14LP Low Profile PTA Balloon Dilatation Catheter Micropuncture Pedal Access Set Silhouette Transitionless - with Nitinol Wire Guide and Hemostatic Valve Cotton Cannulatome II PC Double Lumen Sphincterotome Cannulatome II PC Lumen Sphincterotome Cannulatome II PC Double Lumen Sphincterotome Tri-Tome PC Triple Lumen Sphincterotomes Howell D.A.S.H. Direct Acess System Cotton Cannulatome II PC Protector Howell D.A.S.H. Sphincterotome DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME COTTON CANNULATOME D.A.S.H. Dome Tip Double Lumen Sphincterotome D.A.S.H. Pre-Loaded with Acrobat 2 Wire Guide D.A.S.H. Preloaded with Acrobat Wire Guide Tri-Tome PC Protector UTS PRECURVED ULTRA TAPER SPHINCTEROTOME Universal Active Cord Kumpe Access Catheter HERCULES 3 STAGE BALLOON ESOPHAGEAL HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL - PYLORIC - COLONIC DISPOSABLE VARICES INJECTOR ACUJECT VARIABLE INJECTION NEEDLE Pakter Curved Needle Set Nathanson Transcystic Bile Duct Stone Exploration Pack Wittich Nitinol Stone Basket Guardia Access Nano Embryo Transfer Catheter FUSION LITHOTRIPSY EXTRACTION BASKET MEMORY SOFT WIRE BASKET MEMORY HARD WIRE BASKET THE WEB EXTRACTION BASKET Web II Memory Extraction Basket Memory Eight Wire Basket Memory II Double Lumen Baskets Memory Helical Stone Extractor Basket Lead Clippers Bulldog Lead Extender Sof-Grip Hemostat One-Tie Compression Coil Coil Expander Tesla BiCord Active Cord Teslatome Bipolar Sphincterotome Holmium Laser Fiber Multi Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems Ultraxx Nephrostomy Balloon Set Ultraxx Nephrostomy Balloon Set with TFE Sheath SNAPLOC WIRE GUIDE LOCKING DEVICE Captura Mini Biopsy Forceps W/O Spike Captura Serrated Forceps W/O Spike Captura Biopsy Forceps without Spike Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip Fallopian Tube Catheterization Set TriForce Peripheral Crossing Set Rosch-Uchida Transjugular Liver Access Set Ring Transjugular Intrahepatic Access Set Needle Catheter Combination Stylet Catheter Combination Hiatal Hernia Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether Universa Firm Ureteral Stent Set with Hydrophilic Coating Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe Ultraxx Nephrostomy Balloon with TFE Sheath Initial Placement Gastrostomy Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXM	Prosthesis, Eyelid Spacer/Graft, Biologic	Ophthalmic	Class 2	886.3130	2013-02-04
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-12-22
MQJ	Micromanipulators And Microinjectors, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6150	2019-06-20
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2014-09-04
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-08-28
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2019-03-25
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2007-11-19
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-05-21
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-08-29
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2012-02-23
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2024-05-30
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2016-08-18
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2016-08-18
NXM	Prosthesis, Eyelid Spacer/Graft, Biologic	Ophthalmic	Class 2	886.3130	2013-02-04
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2019-12-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-02-04
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2013-02-04
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2013-02-04
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2013-02-04
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2020-01-15
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2021-11-15
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2014-09-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-02-04
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2013-02-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-02-04
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2018-12-14
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2007-11-27
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-05-21
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-02-04
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2014-03-10
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2019-01-08
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-09-23
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2017-10-18
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2017-03-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-01-16
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2013-02-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-02-04
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2018-01-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-01-27
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2019-09-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-12-22
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2023-12-10
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-09-09
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2017-02-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-06-15
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2023-12-10
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2020-05-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-05-24
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2014-03-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2019-02-07
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2016-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2026-03-20
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2023-12-10
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-02-04
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2007-06-18
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2020-01-15
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-12-24
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2014-07-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-09-09
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-05-19
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2019-01-10
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2013-02-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-05
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2016-01-27
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-11-13
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-02-04
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-03-25
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2013-02-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-12-24
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2016-06-01
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-02-04
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2019-07-17
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2019-09-12
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2019-09-12
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2013-02-04
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1997-01-21
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2004-10-25
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2019-09-09
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1992-12-12
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2013-02-04
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2019-03-25
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2013-02-04
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2020-01-28
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-02-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-04-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-02-26
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2019-06-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2013-02-04
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2024-08-29
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2017-12-22
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-02-04
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2019-02-04
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-04-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-04-30
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2013-11-25
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2015-03-05
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-02-04
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2013-02-04
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2017-02-03
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	General, Plastic Surgery	Class 2	878.3300	2017-02-03
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2013-02-04
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-02-04
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2013-02-04
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2013-02-04
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-05-13
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2019-04-02
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2019-07-12
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2014-03-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-03-05
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2014-03-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOK, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011050534	Cook Incorporated	Canton, IL, US
3012766489	COOK, INC.	Bloomington, IN, US
1825146	Cook Incorporated	Spencer, IN, US
1820334	Cook Incorporated	Bloomington, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K171989	Wilson-Cook Medical, Inc.	Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter	2018-03-20
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Similar Registrations

Registration Number	Establishment Name	Location
3015177648	KATENA PRODUCTS, INC.	Parsippany, NJ, US
2242450	KATENA PRODUCTS, INC.	Randolph, NJ, US
3006891655	Seisa Europe s.r.o.	myjava Trenciansky, SK
3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000393132. Last updated year: 2026. Please use registration number 1000393132 when referencing this establishment in official correspondence.