510(k) K122795 ยท DQX Wire, Guide, Catheter
STINGRAY GUIDEWIRES
| Applicant | Bridgepoint Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 8, 2012 |
| Received | Sep 12, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2018 | Boston Scientific Corporation Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.