SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES


Device Classification Name

system, balloon, intra-aortic and control

510(k) Number K112327
Device Name SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
Applicant
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
1300 macarthur blvd
mahwah, 
NJ 
07430

Applicant Contact helder a sousa
Correspondent
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
1300 macarthur blvd
mahwah, 
NJ 
07430

Correspodent Contact helder a sousa
Regulation Number 870.3535
Classification Product Code
DSP  
Date Received 08/12/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No