K163693 is an FDA 510(k) clearance for the IntraClude Intra-Aortic Occlusion Device. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on January 26, 2017, 29 days after receiving the submission on December 28, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K163693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2016 |
| Decision Date | January 26, 2017 |
| Days to Decision | 29 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 |