K962668 is an FDA 510(k) clearance for the AMR-ACV CLAMPS. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on November 4, 1996, 118 days after receiving the submission on July 9, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K962668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 1996 |
| Decision Date | November 04, 1996 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |