K241330 is an FDA 510(k) clearance for the Fogarty Fortis Arterial Embolectomy Catheter. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on July 2, 2024, 53 days after receiving the submission on May 10, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K241330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2024 |
| Decision Date | July 02, 2024 |
| Days to Decision | 53 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 |