510(k) K172487 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Coaxial Dilator Set (Micro-Introducer)
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Unknown, Oct 16, 2017 |
| Received | Aug 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2018 | Galt Medical Corporation 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11;
2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; Terminated |
DRE | None listed |
| May 2, 2018 | Galt Medical Corporation TVS LPA, Catalog #: DIL-059-00 Terminated |
KGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.