510(k) K970376 ยท DQX Wire, Guide, Catheter
PTCA GUIDEWIRE
| Applicant | Lake Region Mfg., Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 6, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970376
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.