K830818 is an FDA 510(k) clearance for the ASAHI BLOOD/PLASMA PUMP #ABP-01A &. This device is classified as a Pump, Blood, Extra-luminal (Class II - Special Controls, product code FIR).
Submitted by Parker Hannifin Corp. (Walker, US). The FDA issued a Cleared decision on April 12, 1983, 28 days after receiving the submission on March 15, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K830818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1983 |
| Decision Date | April 12, 1983 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIR — Pump, Blood, Extra-luminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |