FDA Product Code
FDA Product Code FIR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961137 | ATI PLASMA PUMP (PP-04) | Apheresis Technologies, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K831953 | INFUSION PUMP | Cryosan, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Parker Hannifin Corp. | 1983-04-12 | Traditional | PDF ↗ |
| K821139 | SPS-SINGLE PATIENT SYSTEM | Extracorporeal Medical Specialities, Inc. | 1982-05-10 | Traditional | PDF ↗ |
| K780410 | BLOOD PUMP-MODE S10K | 3M Health Care, Sarns | 1978-05-03 | Traditional | PDF ↗ |
| K771705 | RS-7800 MINIPUMP | Renal Systems, Inc. | 1977-10-04 | Traditional | PDF ↗ |
| K761050 | HEPARIN PUMP | Dws, Inc. | 1976-12-30 | Traditional | PDF ↗ |
Product code FIR · Class II · Gastroenterology, Urology. Data: openFDA.