510(k) K022071 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
| Applicant | Embol-X, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 14, 2003 |
| Received | Jun 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022071
| 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.