K895074 is an FDA 510(k) clearance for the ANGIOSCOPY PUMP. This device is classified as a Withdrawal/infusion Pump (Class II - Special Controls, product code DQI).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 31, 1990, 170 days after receiving the submission on August 14, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1800.
| 510(k) Number | K895074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 1989 |
| Decision Date | January 31, 1990 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | DQI — Withdrawal/infusion Pump |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1800 |