CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221


Device Classification Name

cannula, catheter

510(k) Number K030398
Device Name CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
Applicant
CARDIAC ASSIST, INC.
240 alpha dr.
pittsburgh, 
PA 
15238

Applicant Contact tim krauskopf
Correspondent
CARDIAC ASSIST, INC.
240 alpha dr.
pittsburgh, 
PA 
15238

Correspodent Contact tim krauskopf
Regulation Number 870.1300
Classification Product Code
DQR  
Date Received 02/06/2003
Decision Date 05/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No