K240078 is an FDA 510(k) clearance for the Fogarty Thru-Lumen Embolectomy Catheter. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 28, 2024, 230 days after receiving the submission on January 11, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K240078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2024 |
| Decision Date | August 28, 2024 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |