510(k) K113103 ยท PNO Catheter, Percutaneous, Cutting/Scoring
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
| Applicant | Rex Medical, Great Neck NY, US |
| Decision | Substantially Equivalent, May 22, 2012 |
| Received | Oct 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113103
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.