510(k) K062387 ยท PNO Catheter, Percutaneous, Cutting/Scoring
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 5, 2006 |
| Received | Aug 15, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062387
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.