510(k) K141547 ยท DQY Catheter, Percutaneous
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
| Applicant | Reflow Medical, San Clemente CA, US |
| Decision | Substantially Equivalent, Sep 30, 2014 |
| Received | Jun 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2017 | ReFlow Medical Wingman 35 Crossing Catheter, 65cm,
Model Numbers:
WGM35065US
WGM35065CE
WGM35090US
WGM35090CE
WGM35135US
WGM35135CE Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.