BJORK-SHILEY CARDIAC VALVE
FDA premarket approval P780008/S015 · decided 1984-11-26
Approval details
- PMA number
- P780008
- Supplement
- S015
- Trade name
- BJORK-SHILEY CARDIAC VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Shiley, Inc.
- Date received
- 1983-12-08
- Decision date
- 1984-11-26
- Days to decision
- 354 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SHILEY PERFUSION TUBING SETS (K920594) | Shiley, Inc. | 1993-03-18 |
| SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (K910991) | Shiley, Inc. | 1991-11-27 |
| SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (K911876) | Shiley, Inc. | 1991-08-09 |
| BCD ADVANCED (K910923) | Shiley, Inc. | 1991-04-09 |
| BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (K901548) | Shiley, Inc. | 1991-01-14 |
| SHILEY SPECIALIZED TRACHEOSTOMY TUBE (K903435) | Shiley, Inc. | 1990-10-02 |
| SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (K901624) | Shiley, Inc. | 1990-07-03 |
| PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (K901250) | Shiley, Inc. | 1990-06-11 |