510(k) K102176 ยท DRA Catheter, Steerable
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
| Applicant | Medtronic Cryocath, LP, Kirkland, CA |
| Decision | Substantially Equivalent, Sep 1, 2010 |
| Received | Aug 3, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2011 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of cathe Terminated |
DRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.