510(k) K831769 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
VARIOUS CARDIOVASCULAR SURGICAL DEVICE
| Applicant | Research Industries Corp., Walker MI, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | Jun 1, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831769
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2008 | Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614
Intended for cannula drainage of the superior and inferior vena cava during ex Terminated |
DWF | None listed |
| Sep 26, 2008 | Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
Intended for cannula drainage of the superior and inferior vena cava during Terminated |
DWF | None listed |
| Sep 26, 2008 | Edwards Lifesciences Research Medical, Inc. Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O, 33/43 Fr. x 39 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
Intended for cannula drainage of the superior and infer Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm
Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm., Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm
Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm, Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 23 cm, Edwards Lifesciences Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.