Panels › Gastroenterology, Urology › Product code FIR · Class 2
Pump, Blood, Extra-Luminal
Regulation 876.5820
0510(k)s in 12 months (7 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in FIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Apheresis Technologies, Inc. | 1 | 3 |
| 3M Health Care, Sarns | 1 | 0 |
| Cryosan, Inc. | 1 | 0 |
| Dws, Inc. | 1 | 0 |
| Extracorporeal Medical Specialities, Inc. | 1 | 0 |
| Parker Hannifin Corp. | 1 | 0 |
| Renal Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 1996 | K961137 | ATI PLASMA PUMP (PP-04) Apheresis Technologies, Inc. | FIR |
| Jul 19, 1983 | K831953 | INFUSION PUMP Cryosan, Inc. | FIR |
| Apr 12, 1983 | K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & Parker Hannifin Corp. | FIR |
| May 10, 1982 | K821139 | SPS-SINGLE PATIENT SYSTEM Extracorporeal Medical Specialities, Inc. | FIR |
| May 3, 1978 | K780410 | BLOOD PUMP-MODE S10K 3M Health Care, Sarns | FIR |
| Oct 4, 1977 | K771705 | RS-7800 MINIPUMP Renal Systems, Inc. | FIR |
| Dec 30, 1976 | K761050 | HEPARIN PUMP Dws, Inc. | FIR |
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