510(k) K140406 ยท DYB Introducer, Catheter
DESTINO TWIST, STEERABLE GUIDING SHEATH
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Apr 17, 2014 |
| Received | Feb 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2021 | Oscor Inc. Destino Twist 14F (also branded as Guidestar 14F) Completed |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.