DAVOL SILICONE SHEATH SUMP DRAIN
FDA 510(k) clearance K810158 · decided 1981-02-13
Clearance details
- K-number
- K810158
- Device name
- DAVOL SILICONE SHEATH SUMP DRAIN
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-21
- Decision date
- 1981-02-13
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- GBS
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ATRIUMS PDR THORACIC CATHETER (K912645) | Atrium Medical Corp. | 1991-09-13 |
| AXIOM ATRAUM WOUND DRAINS (K883887) | Axiom, Inc. | 1989-02-17 |
| INTRODUCTION/DRAINAGE CATHETER & ACCESS (K881873) | Sheridan Catheter Corp. | 1988-05-18 |
| URESIL WOUND DRAIN TROCAR (K880895) | Uresil Corp. | 1988-03-14 |
| NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (K880376) | Genesis Industries, Inc. | 1988-02-16 |
| CLOSED CHEST DRAINAGE SET W/SUTURES (K873377) | Gish Biomedical, Inc. | 1987-10-28 |
| AN3000 MAHONEY DRAIN (K872460) | H.W. Andersen Products, Inc. | 1987-07-23 |
| AN3100 MULHOLLAND DRAIN (K872459) | H.W. Andersen Products, Inc. | 1987-07-21 |
| AN3500 WORTH DRAIN (K872457) | H.W. Andersen Products, Inc. | 1987-07-21 |
| HCI ALL PURPOSE DRAIN/CATHETER SET (K870015) | Health Care Innovations, Inc. | 1987-02-06 |
| URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (K863560) | Uresil Corp. | 1986-09-29 |
| THORACIC CATHETER (CHEST DRAINAGE TUBE) (K863142) | Sheridan Catheter Corp. | 1986-08-29 |
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 |