510(k) K974640 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
COAXIAL DILATOR SET
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Mar 13, 1998 |
| Received | Dec 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Boston Scientific Corporation VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Fi Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.