BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
FDA 510(k) clearance K910318 · decided 1994-08-18
Clearance details
- K-number
- K910318
- Device name
- BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-24
- Decision date
- 1994-08-18
- Days to decision
- 1302 days
- Clearance type
- Traditional
- Product code
- MJC
- 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
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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 |
|---|---|---|
| Wellead® Latex Foley Catheter (K233094) | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 |
| BARDEX I.C. LATEX FOLEY CATHETER (K040658) | C.R. Bard, Inc. | 2004-09-29 |
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |
| SPECTRUM SILICONE FOLEY CATHETER (K000251) | Cook Urological, Inc. | 2000-08-30 |
| RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143) | Rochester Medical Corp. | 2000-07-07 |
| BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464) | C.R. Bard, Inc. | 1999-12-10 |
| BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136) | Bard Medical Div. | 1999-02-16 |
| BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101) | C.R. Bard, Inc. | 1998-11-03 |
| SILICONE ANTIBACTERIAL FOLEY CATHETER (K971627) | Rochester Medical Corp. | 1998-01-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLo recall (Z-2522-2021) | C.R. Bard Inc | 2021-09-23 |
| Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLo recall (Z-2524-2021) | C.R. Bard Inc | 2021-09-23 |
| Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLoc recall (Z-2526-2021) | C.R. Bard Inc | 2021-09-23 |
| SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119 recall (Z-0803-2019) | Bard Medical Division | 2019-02-06 |
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 |