510(k) K003483 ยท DQX Wire, Guide, Catheter
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
| Applicant | Lake Region Mfg., Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 6, 2000 |
| Received | Nov 9, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003483
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.