Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1313046

FEI Number

1313046

Entity Name

C.R. BARD, INC.

City/State/Country

Queensbury, NY, US

Establishment Address

289 Bay Rd, Queensbury, NY 12804, US

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

Balloon Bipolar Temporary Pacing Electrode Catheter Silicone Ureteral Coil Stent with Figure Four End Fluoro-4 Silicone Ureteral Coil Stent Fluoro-4 Silicone Ureteral Stent Urinary Diversion Stent Bard Silicone Ureteral Stenting Denali Vena Cava Filter, Jugular/Subclavian Delivery Kit Denali Vena Cava Filter, Femoral Delivery Kit Inlay Optima Multi-Length Ureteral Stent Inlay Optima Ureteral Stent Dynamic Tip Steerable Catheter Conquest PTA Dilatation Catheter True Flow Valvulplasty Perfusion Catheter CS Assist Diagnostic Catheter Radia XT Steerable Diagnostic Catheter EP XT Steerable Catheter Dynamic XT Steerable Catheter Stinger S Stinger SM Scorpion Stinger Stinger M distal tip electrodes & TempLink/ Scorpion 2 and Scorpion 2M Ablation Catheters all with 4mm or 5mm TempLink M Extension Cables Crosser Generator Crosser CTO Recanalization Catheter PTFE Coated Angiography Guide wires & PTFE Coated Angiography Guide Wires with BH Coating Bard Woven Phillips Follower PHILLIPS AND HEYMAN Bard Heyman Follower Straight Tip Recon Support Catheter Lutonix 018 Drug Coated Balloon PTA Catheter Lutonix 035 Drug Coated Balloon PTA Catheter Lutonix Drug Coated Balloon Orbiter PV Diagnostic Electrode Crosser iQ CTO Recanalization System NBIH Temporary Pacing Electrode Catheter Balloon Bipolar Temporary Pacing Electrode Catheter, Right Heart Curve Balloon Bipolar Temporary Pacing Electrode Catheter Semi-Floating Temporary Pacing Electrode Catheter GOETZ Temporary Pacing Electrode Catheter Bard Red Rubber Utility Catheter SureStep Intermittent Catheter Tray Lutonix Drug Coated Balloon Lutonix 014 PTCA Drug Coated Balloon Catheter Eagle Inflation Device Inlay Ureteral Stent with Hydroglid Inlay VersaFit Multilength Ureteral Inlay Uteral Stent Inlay VersaFit Ureteral Stent Intravascular Catheter Securement Device UltraScore Focused Force PTA Balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-01-31
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2009-07-10
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2016-09-13
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-02-27
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-01-31
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-14
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2017-12-18
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-01-31
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-02-08
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2016-08-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-10-19
FBW	Filiform And Filiform Follower	Gastroenterology, Urology	Class 1	876.5520	2007-03-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-07-28
PRC	Drug-Coated Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2017-08-27
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2007-02-27
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-02-08
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2021-08-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-28
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2026-05-28
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-12
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2014-11-12
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2008-02-13
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-10
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-10-31
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2018-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Z-0041-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

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1061927	INTERNATIONAL STERILIZATION LABORATORY, LLC	GROVELAND, FL, US
2024168	ABBOTT VASCULAR	Temecula, CA, US
3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1313046. Last updated year: 2026. Please use registration number 1313046 when referencing this establishment in official correspondence.