510(k) K853746 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
| Applicant | Advanced Cardiovascular Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 21, 1985 |
| Received | Sep 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853746
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.