Submission Details
| 510(k) Number | K210647 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
Apr 2021
Decision
58d
Days
Class 2
Risk
About This 510(k) Submission
K210647 is an FDA 510(k) clearance for the SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, LLC (Maple Grove, 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 review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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