ADVANTA T-GRAFT

Device Classification Name

prosthesis, vascular graft, of 6mm and greater diameter

510(k) Number K051332
Device Name ADVANTA T-GRAFT
Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson, 
NH 
03051

Applicant Contact karen hall
Correspondent
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson, 
NH 
03051

Correspodent Contact karen hall
Regulation Number 870.3450
Classification Product Code
DSY  
Date Received 05/23/2005
Decision Date 09/29/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls