510(k) K181817 ยท DYB Introducer, Catheter
transGlideXT Expandable Introducer
| Applicant | Transaortic Medical, Inc., Morgan Hill CA, US |
| Decision | Substantially Equivalent, Mar 26, 2019 |
| Received | Jul 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2020 | Medtronic Vascular Galway DBA Medtronic Ireland Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.