K070323 is an FDA 510(k) clearance for the TEMPORARY LIMB SALVAGE SHUNT. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on February 15, 2007, 13 days after receiving the submission on February 2, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K070323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2007 |
| Decision Date | February 15, 2007 |
| Days to Decision | 13 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 |