510(k) K000011 ยท DQX Wire, Guide, Catheter
MODIFIED HYDROPHILIC COATED GUIDEWIRE
| Applicant | Lake Region Mfg., Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 1, 2000 |
| Received | Jan 3, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000011
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.