HEARTSTRING III PROXIMAL SEAL SYSTEM


Device Classification Name

clamp, vascular

510(k) Number K080169
Device Name HEARTSTRING III PROXIMAL SEAL SYSTEM
Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
170 baytech drive
san jose, 
CA 
95134

Applicant Contact elizabeth trujillo
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 01/24/2008
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No