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


Device Classification Name

cannula, catheter

510(k) Number K073559
Device Name 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 south 300 west
midvale, 
UT 
84047

Applicant Contact john w nicholson
Correspondent
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 south 300 west
midvale, 
UT 
84047

Correspodent Contact john w nicholson
Regulation Number 870.1300
Classification Product Code
DQR  
Date Received 12/19/2007
Decision Date 01/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No