510(k) K112541 ยท DRA Catheter, Steerable
Z FLEX-270TM STEERABLE SHEATH
| Applicant | Great Batch Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 7, 2012 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2012 | Greatbatch Medical Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Med Terminated |
DRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.