K113182 is an FDA 510(k) clearance for the EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on December 7, 2011, 40 days after receiving the submission on October 28, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K113182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2011 |
| Decision Date | December 07, 2011 |
| Days to Decision | 40 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |