510(k) K012534 ยท DQX Wire, Guide, Catheter
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
| Applicant | Advanced Cardiovascular Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jan 24, 2002 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012534
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.