WILLIAM HARVEY OXYGENATING GAS FILTER
FDA 510(k) clearance K802906 · decided 1980-12-16
Clearance details
- K-number
- K802906
- Device name
- WILLIAM HARVEY OXYGENATING GAS FILTER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-17
- Decision date
- 1980-12-16
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KRI
- Device class
- 1
- Regulation number
- 870.4200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Warrendale, PA, US
- Third-party review
- No
- Expedited review
- No
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| CARDIO2 CYCLE (K926233) | Ergometrix, Inc. | 1993-06-04 |
| TUBE GRIP (K922404) | Georgia Medical Products, Inc. | 1992-11-23 |
| NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856) | Acacia Laboratories, Inc. | 1989-11-08 |
| CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (K884893) | American Omni Medical, Inc. | 1989-01-30 |
| CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (K884640) | American Omni Medical, Inc. | 1989-01-24 |
| HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (K874605) | Mallinckrodt Critical Care | 1988-02-02 |
| CPE 2000 CARDIO PULMONARY ERGOMETER (K874925) | Medical Graphics Corp. | 1988-01-19 |
| STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP (K864890) | Shiley, Inc. | 1987-02-19 |
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 |