510(k) K851854 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
| Applicant | Advanced Cardiovascular Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Aug 5, 1985 |
| Received | Apr 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851854
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.