K210647 is an FDA 510(k) clearance for the SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Vascular Solutions, LLC (Minneapolis, US). The FDA issued a Cleared decision on April 30, 2021, 58 days after receiving the submission on March 3, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K210647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2021 |
| Decision Date | April 30, 2021 |
| Days to Decision | 58 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 |