Submission Details
| 510(k) Number | K211240 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 26, 2021 |
| Decision Date | August 26, 2021 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
ViperCross Support Catheters
Aug 2021
Decision
122d
Days
Class 2
Risk
About This 510(k) Submission
K211240 is an FDA 510(k) clearance for the ViperCross Support Catheters, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cardiovascular Systems, Inc. (St Paul, US). The FDA issued a Cleared decision on August 26, 2021, 122 days after receiving the submission on April 26, 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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