K112662 is an FDA 510(k) clearance for the MICROFRANCE(R) WORMALD VASCULAR CLAMP. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 20, 2012, 129 days after receiving the submission on September 13, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K112662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2011 |
| Decision Date | January 20, 2012 |
| Days to Decision | 129 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 |