510(k) K140768 ยท DYB Introducer, Catheter
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
| Applicant | Lepu Medical Technology (Bejing) Co., Ltd., South Euclid OH, US |
| Decision | Substantially Equivalent, Nov 25, 2014 |
| Received | Mar 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140768
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.