Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681442

FEI Number

3002806368

Entity Name

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

City/State/Country

KARLSRUHE Baden-Wurttemberg, DE

Establishment Address

WACHHAUSSTRASSE 6, KARLSRUHE Baden-Wurttemberg 76227, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LifeStent XL Biliary Stent System LifeStent Biliary Stent System LifeStent 5F Vascular Stent System Lifestent Solo Vascular Stent System Lifestent and Lifestent XL Vascular Stent System Bardex Double Pigtail Stent Bard Lubricious-Coated Ureteral Stent with Suture Coil Stent Bardex Double Pigtail Ureteral Stent with Suture Bard Fluoro-4 Silicone Ureteral Stent Ureteral Coil Stent with Figure Four End LifeStent Biliary Stent System LifeStent XL Biliary Stent System Covera Vascular Covered Stent Fluency Plus Endovascular Stent Graft LifeStent Biliary Stent System Lifestent XL Biliary Stent System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-02-06
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2009-06-12
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-08-13
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2018-07-30
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2014-08-04
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-02-06
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1999-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Joni Anderson Email: joni.anderson@bd.com Phone: (480) 2662981

Related Public Records

Same Entity

C. R. Bard, 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
1725056	MEDIVANCE, INC.	LOUISVILLE, CO, US
3006513822	Lutonix, Inc.	Tempe, AZ, US
1223089	DAVOL INC.	WOBURN, MA, US
3002504068	Bard European Distribution Center NV	Olen Antwerpen, BE
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902734	Olympus Corp.	PR CANNULAS	1990-08-22

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681442. Last updated year: 2026. Please use registration number 9681442 when referencing this establishment in official correspondence.