Atlas FDA

BARD FLEXIBLE TIP URETERAL CATHETER

FDA 510(k) clearance K950300 · decided 1995-04-27

Clearance details

K-number
K950300
Device name
BARD FLEXIBLE TIP URETERAL CATHETER
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1995-01-25
Decision date
1995-04-27
Days to decision
92 days
Clearance type
Traditional
Product code
EYB
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Covington, GA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch C.R. Bard

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RocaTub Ureteral Catheter (K192183)Promepal Sam2020-04-23
Dornier MINNOW Ureteral Catheter (K191187)Dornier Medtech America, Inc.2019-09-18
UPJ Occlusion Balloon Catheter (K183323)Cook Incorporated2019-08-05
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (K182695)Cook Incorporated2019-06-17
Ureteric Catheters (K182122)Coloplast Corp.2018-10-04
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182)Cook Incorporated2018-09-14
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043)Coloplast Corp.2017-12-21
OCCLUDER OCCLUSION BALLOON CATHETER (K133750)Boston Scientific Corporation2014-01-08
MEDLINE RED RUBBER URETHRAL CATHETER (K092250)Medline Industries, Inc.2010-01-21
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (K083788)Endooptiks, Inc.2009-03-03
DUAL LUMEN CATHETER (K043581)Acmi Corporation2005-03-03
AMSURE RED RUBBER URETHRAL CATHETER (K030293)Amsino International, Inc.2004-02-04

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01