K161962 is an FDA 510(k) clearance for the VAMP Venous/Arterial Blood Management Protection System. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 28, 2016, 133 days after receiving the submission on July 18, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K161962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2016 |
| Decision Date | November 28, 2016 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |