K885281 is an FDA 510(k) clearance for the VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 3, 1989, 66 days after receiving the submission on December 27, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K885281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1988 |
| Decision Date | March 03, 1989 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |