EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K110103
Device Name EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
Applicant
EDWARDS LIFESCIENCES LLC
12050 lone peak parkway
draper, 
UT 
84020 -0000

Applicant Contact spencer walker
Correspondent
EDWARDS LIFESCIENCES LLC
12050 lone peak parkway
draper, 
UT 
84020 -0000

Correspodent Contact spencer walker
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 01/13/2011
Decision Date 02/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No