510(k) K031916 ยท DQX Wire, Guide, Catheter
GALT MEDICAL GUIDEWIRE
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Substantially Equivalent, Jul 17, 2003 |
| Received | Jun 20, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031916
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Medical Components, Inc dba MedComp CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other in Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.