ATRIUM FLIXENE IFG VASCULAR GRAFT


Device Classification Name

prosthesis, vascular graft, of 6mm and greater diameter

510(k) Number K122138
Device Name ATRIUM FLIXENE IFG VASCULAR GRAFT
Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr
hudson, 
NH 
03051

Applicant Contact megan mccagh
Correspondent
ATRIUM MEDICAL CORP.
5 wentworth dr
hudson, 
NH 
03051

Correspodent Contact megan mccagh
Regulation Number 870.3450
Classification Product Code
DSY  
Date Received 07/19/2012
Decision Date 08/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls