Company ยท US
Edwards Lifesciences Research Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2008. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2008 | K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II Edwards Lifesciences Research Medical | DQR |
| Sep 27, 2006 | K062429 | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH Edwards Lifesciences Research Medical | DTM |
| Oct 1, 1999 | K990396 | T-ANASTAFLO Edwards Lifesciences Research Medical | DWF |
| Jul 2, 1999 | K991170 | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 Edwards Lifesciences Research Medical | DWF |
| Jun 11, 1999 | K983791 | PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA Edwards Lifesciences Research Medical | DWF |
| Dec 1, 1998 | K974259 | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE Edwards Lifesciences Research Medical | DWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2009 | Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards
Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, t Terminated |
DXC | K955132 K962510 +2 |
| Nov 6, 2009 | Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile
R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr Terminated |
DXC | K955132 K962510 +1 |
| Jan 5, 2009 | Edwards Lifesciences Research Medical, Inc. CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated Terminated |
DXC | K964161 |
| Jan 5, 2009 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in p Terminated |
DXC | K964161 |
| 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 | K831769 |
| 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 | K831769 |
| 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 | K831769 |
| Sep 11, 2008 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing. Terminated |
DWF | K033464 K891576 |
| Sep 11, 2008 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing. Terminated |
DWF | K033464 K891576 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences Terminated |
DWF | None listed |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 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 | K831769 |
| 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 | K831769 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm
Edwards Lifesciences Terminated |
DWF | K831769 |
| 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 | K831769 |
| Jun 9, 2006 | Edwards Lifesciences Research Medical, Inc. Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm
Edwards Lifesciences Terminated |
DWF | K831769 |
| Dec 15, 2004 | Edwards Lifesciences Research Medical Inc EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. Terminated |
DWF | K020693 |