510(k) K102420 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Oct 26, 2010 |
| Received | Aug 25, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
The E Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.