HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
FDA 510(k) clearance K910197 · decided 1991-08-09
Clearance details
- K-number
- K910197
- Device name
- HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-16
- Decision date
- 1991-08-09
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- EZC
- 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 |
|---|---|---|
| Rusch Intermittent Urethral Catheters (K222279) | Teleflex Medical | 2022-08-29 |
| Rusch Intermittent Urethral Catheters (K173596) | Teleflex Medical | 2018-01-29 |
| UNIVERSAL URETHRAL CATHETER (K946282) | Louisville Laboratories, Inc. | 1995-03-31 |
| BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (K913341) | C.R. Bard, Inc. | 1992-01-27 |
| BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF (K910846) | C.R. Bard, Inc. | 1991-08-16 |
| BARD HYDROGEL-COATED FOLEY CATHETERS (K910195) | C.R. Bard, Inc. | 1991-08-09 |
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 |