510(k) K150634 ยท PNO Catheter, Percutaneous, Cutting/Scoring
AngioSculpt PTA Scoring Baloon Catheters
| Applicant | Spectranetrics, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Apr 8, 2015 |
| Received | Mar 11, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150634
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.