K201811 is an FDA 510(k) clearance for the coraForce and coraFlex Support Catheters. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on October 26, 2020, 117 days after receiving the submission on July 1, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K201811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2020 |
| Decision Date | October 26, 2020 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |