510(k) K000737 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
COAXIAL DILATOR SET
| Applicant | Xentek Medical, Inc., Athens TX, US |
| Decision | Substantially Equivalent, Aug 1, 2000 |
| Received | Mar 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000737
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Galt Medical Corporation Boston Scientific Enhance Transcarotid/Peripheral Access Kit
REF: SR-4F21G7D-MP (Kit-075-03)
Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube Open, Classified |
DQX | None listed |
| May 7, 2025 | Galt Medical Corporation B Braun Interventional Coaxial Dilator
REF:
KIT-018-47,
KIT-019-67,
KIT-018-41,
KIT-019-37
These Micro-Introducer Kits are intended to introduce up to a .038 inch
guidewire or catheter into the vascu Open, Classified |
DRE | None listed |
| 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 |
| May 11, 2010 | Galt Medical Corp Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369. Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.