K202049 is an FDA 510(k) clearance for the Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on September 7, 2021, 410 days after receiving the submission on July 24, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K202049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2020 |
| Decision Date | September 07, 2021 |
| Days to Decision | 410 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |