510(k) K021990 ยท DQX Wire, Guide, Catheter
GALT MEDICAL GUIDEWIRE
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Substantially Equivalent, Jul 18, 2002 |
| Received | Jun 18, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021990
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.