510(k) K972512 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
| Applicant | Boston Scientific Scimed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 12, 1998 |
| Received | Jul 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972512
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.