510(k) K193548 ยท DQX Wire, Guide, Catheter
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 18, 2020 |
| Received | Dec 20, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193548
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.