510(k) K123370 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Mar 13, 2013 |
| Received | Nov 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2019 | Edwards Lifesciences, LLC EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI):
EZC21A (00690103174 Terminated |
DWF | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. Terminated |
DWF | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. Terminated |
DWF | None listed |
| Nov 1, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only,
Product Usage:
Edwards Lifesciences femoral access cannulae are intend Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.