510(k) K120780 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | Mar 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2013 | Edwards Lifesciences, LLC Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9.
Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.