EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER


Device Classification Name

clamp, vascular

510(k) Number K112694
Device Name EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy
draper, 
UT 
84020

Applicant Contact spencer walker
Correspondent
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy
draper, 
UT 
84020

Correspodent Contact spencer walker
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 09/15/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No