510(k) K853100 ยท DYB Introducer, Catheter
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT
| Applicant | Cobe Laboratories, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 25, 1985 |
| Received | Jul 23, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853100
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.