BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM


Device Classification Name

clamp, vascular

510(k) Number K072297
Device Name BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
Applicant
CARDIVA MEDICAL, INC.
155 moffett park dr.,
suite a-210
sunnyvale, 
CA 
94089

Applicant Contact kit cariquitan
Correspondent
CARDIVA MEDICAL, INC.
155 moffett park dr.,
suite a-210
sunnyvale, 
CA 
94089

Correspodent Contact kit cariquitan
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 08/17/2007
Decision Date 09/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No