510(k) K142684 ยท DYB Introducer, Catheter
FlexCath Select Steerable Sheath (10 French)
| Applicant | Medtronic Cryocath, LP, Mounds View MN, US |
| Decision | Substantially Equivalent, Nov 6, 2014 |
| Received | Sep 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065.
The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of t Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.