CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES


Device Classification Name

prosthesis, vascular graft, of 6mm and greater diameter

510(k) Number K103347
Device Name CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Applicant
INTERVASCULAR, SAS
zone industrielle athelia i
laciotat, 

FR

13705

Applicant Contact philippe bensimon
Correspondent
INTERVASCULAR, SAS
zone industrielle athelia i
laciotat, 

FR

13705

Correspodent Contact philippe bensimon
Regulation Number 870.3450
Classification Product Code
DSY  
Date Received 11/15/2010
Decision Date 02/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No