510(k) K821188 ยท DYB Introducer, Catheter
INTRODUCER SET
| Applicant | Advanced Cardiovascular Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 8, 1982 |
| Received | Apr 27, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821188
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.