Submission Details
| 510(k) Number | K083139 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 2008 |
| Decision Date | November 25, 2008 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
VIPERSPHERE PTA BALLOON CATHETER
Nov 2008
Decision
33d
Days
Class 2
Risk
About This 510(k) Submission
K083139 is an FDA 510(k) clearance for the VIPERSPHERE PTA BALLOON CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cardiovascular Systems, Inc. (Saint Paul, US). The FDA issued a Cleared decision on November 25, 2008, 33 days after receiving the submission on October 23, 2008. 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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