510(k) K110133 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
| Applicant | Creganna-Tactx Medical, Campbell CA, US |
| Decision | Substantially Equivalent, Jun 10, 2011 |
| Received | Jan 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2014 | Cordis Corporation Cordis EMPIRA NC RX PTCA Dilatation Catheter Terminated |
LOX | None listed |
| Aug 28, 2014 | Cordis Corporation Cordis EMPIRA RX PTCA Dilatation Catheter Terminated |
LOX | None listed |
| Jun 11, 2014 | Cordis Corporation Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. Terminated |
LOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.