HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX


Device Classification Name

graft, vascular, synthetic/biologic composite

510(k) Number K122612
Device Name HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
Applicant
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne, 
NJ 
07470

Applicant Contact marylou insinga
Correspondent
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne, 
NJ 
07470

Correspodent Contact marylou insinga
Regulation Number 870.3450
Classification Product Code
MAL  
Date Received 08/27/2012
Decision Date 09/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No