510(k) K110051 ยท DYB Introducer, Catheter
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
| Applicant | Great Batch Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 2, 2012 |
| Received | Jan 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2013 | Greatbatch Medical Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.