CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
FDA 510(k) clearance K890504 · decided 1989-03-10
Clearance details
- K-number
- K890504
- Device name
- CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-01
- Decision date
- 1989-03-10
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JOD
- Device class
- 2
- Regulation number
- 870.4270
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| GAS FILTER (K993060) | Olson Medical Sales, Inc. | 2000-03-28 |
| PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (K875095) | Pall Biomedical Products Co. | 1988-02-29 |
| PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (K874405) | Pall Biomedical Products Co. | 1987-12-30 |
| SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 (K855067) | Cobe Laboratories, Inc. | 1986-02-26 |
| CARDIO METRICS CARDIOTOMY RESERVOIR (K841958) | Sterile Design, Inc. | 1984-10-15 |
| CARDIOTOMY FILTER (K830634) | Texas Medical Products, Inc. | 1983-06-30 |
| INTERFACE CARDIOTOMY BLOOD FILTER #50 (K823259) | Medical, Inc. | 1982-11-24 |
| INTERFACE CARDIOTOMY BLOOD FILTER #51 (K823260) | Medical, Inc. | 1982-11-24 |
| INTERFACE CARDIOTOMY BLOOD FILTER #51 (K812243) | Medical, Inc. | 1981-08-25 |
| INTERFACE CARDIOTOMY BLOOD FILTER (K781383) | Medical, Inc. | 1978-09-27 |
| EXTRACORPEAL CARDIOTOMY BLOOD FILTER (K780653) | Cobe Laboratories, Inc. | 1978-06-14 |
Recalls involving this device
No recalls on record reference this clearance.