K193379 is an FDA 510(k) clearance for the Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe. 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 June 12, 2020, 190 days after receiving the submission on December 5, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K193379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2019 |
| Decision Date | June 12, 2020 |
| Days to Decision | 190 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 |