Medical Device Manufacturer · US , Midvale , UT

Edwards Lifesciences Research Medical - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1998

Recent clearances: T-ANASTAFLO, RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014, PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Edwards Lifesciences Research Medical Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jan 31, 2008

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION...

Cardiovascular · 43d

Cleared Sep 27, 2006

MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE,...

Cardiovascular · 37d

Cleared Oct 01, 1999

Cardiovascular · 234d

Cleared Jul 02, 1999

RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014

Cardiovascular · 86d

Cleared Jun 11, 1999

PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA

Cardiovascular · 227d

Cleared Dec 01, 1998

VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE

Cardiovascular · 383d