FIR — Pump, Blood, Extra-Luminal Class II
FDA product code FIR covers "Pump, Blood, Extra-Luminal", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIR
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961137 | Apheresis Technologies | ATI PLASMA PUMP (PP-04) | Jun 14, 1996 |
| K831953 | Cryosan | INFUSION PUMP | Jul 19, 1983 |
| K830818 | Parker Hannifin | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Apr 12, 1983 |
| K821139 | Extracorporeal Medical Specialities | SPS-SINGLE PATIENT SYSTEM | May 10, 1982 |
| K780410 | 3M Health Care, Sarns | BLOOD PUMP-MODE S10K | May 3, 1978 |
| K771705 | Renal Systems | RS-7800 MINIPUMP | Oct 4, 1977 |
| K761050 | Dws | HEPARIN PUMP | Dec 30, 1976 |