510(k) K140015 ยท DYB Introducer, Catheter
CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
| Applicant | Cardiosolutions, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Feb 5, 2014 |
| Received | Jan 2, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140015
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.