Submission Details
| 510(k) Number | K211251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 26, 2021 |
| Decision Date | May 26, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
ViperCath XC Peripheral Exchange Catheter
May 2021
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K211251 is an FDA 510(k) clearance for the ViperCath XC Peripheral Exchange Catheter, 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 May 26, 2021, 30 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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