510(k) K080364 ยท DQX Wire, Guide, Catheter
FINDRWIRZ GUIDE WIRE SYSTEM
| Applicant | Sentreheart, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Aug 11, 2008 |
| Received | Feb 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2016 | SentreHeart Inc FindrWIRZ Guidewire System Catalog# 40-05
Cardiology:
The system is intended for use in the cardiovascular system for
introduction and positioning of over the-wire catheters and therapeutic devices d Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.