510(k) K081220 ยท PNO Catheter, Percutaneous, Cutting/Scoring
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
| Applicant | Angioscore, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, May 28, 2008 |
| Received | Apr 30, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081220
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.