510(k) K101339 ยท DQX Wire, Guide, Catheter
ARCHER SUPER STIFF GUIDEWIRES
| Applicant | Medtronic, Inc., Santa Rosa CA, US |
| Decision | Substantially Equivalent, Aug 31, 2010 |
| Received | May 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W.
Intended to facilitate catheter placement and exchange during procedures in the aorta. Terminated |
DQX | None listed |
| Mar 28, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide.
Product Usage:
The Medtronic Archer 0.035 inch (0.89mm) Super Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.