510(k) K041993 ยท PNO Catheter, Percutaneous, Cutting/Scoring
2 CM PERIPHERAL CUTTING BALOON
| Applicant | Boston Scientific Ivt, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | Jul 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041993
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.