510(k) K950752 ยท DQX Wire, Guide, Catheter
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
| Applicant | Advanced Cardiovascular Systems, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, May 15, 1995 |
| Received | Feb 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950752
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2011 | Abbott Vascular Abbott Vascular ACS .035 Torque Device
Part Number : 1003279.
For use in cardiac diagnostic or therapeutic procedures. Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.