BARD MALE EXTERNAL CATHETER
FDA 510(k) clearance K802433 · decided 1980-10-31
Clearance details
- K-number
- K802433
- Device name
- BARD MALE EXTERNAL CATHETER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-06
- Decision date
- 1980-10-31
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- KNX
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Warrendale, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IBAG (K110518) | Future Path Medical, LLC | 2011-06-24 |
| 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (K973364) | Maersk Medical A/S | 1998-03-17 |
| MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (K972887) | Medline Industries, Inc. | 1997-12-11 |
| BESECURE EXTERNAL URINARY COLLECTION SYSTEM (K971271) | Urology Research Intl., Inc. | 1997-08-18 |
| AMSINO URINARY LEG BAG (K971929) | Amsino Intl., Inc. | 1997-08-06 |
| WELCON HUE-VU URINARY DRAINAGE BAG (K971764) | Welcon, Inc. | 1997-07-29 |
| LIBERTY VALVE (K964690) | Cleveland Medical Devices, Inc. | 1997-03-21 |
| AMSINO URINARY DRAINAGE BAG (K964745) | Amsino Intl., Inc. | 1997-03-18 |
| URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (K962652) | Customed, Inc. | 1996-10-04 |
| PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (K960949) | Bristol-Myers Squibb | 1996-04-19 |
| PROSYS LEG BAG (K952208) | Convatec, A Division of E.R. Squibb & Sons | 1995-08-15 |
| ORION'S URINARY DRAINAGE SET (K944377) | Regulatory & Marketing Services, Inc. | 1994-12-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |