510(k) K032146 ยท DQX Wire, Guide, Catheter
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
| Applicant | Precision Vascular Systems, Inc., West Valley City UT, US |
| Decision | Substantially Equivalent, Aug 12, 2003 |
| Received | Jul 14, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2024 | Stryker Neurovascular The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.0 Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.