K905189 is an FDA 510(k) clearance for the BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL). 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 30, 1991, 72 days after receiving the submission on November 19, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1800.
| 510(k) Number | K905189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1990 |
| Decision Date | January 30, 1991 |
| Days to Decision | 72 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 |