510(k) K130559 ยท DYB Introducer, Catheter
MOBICATH BI-DIRECTIONAL GUIDING SHEATH
| Applicant | Great Batch Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, May 24, 2013 |
| Received | Mar 4, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2017 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve).
The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.