510(k) K083139 ยท DQY Catheter, Percutaneous
VIPERSPHERE PTA BALLOON CATHETER
| Applicant | Cardiovascular Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Nov 25, 2008 |
| Received | Oct 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083139
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.