ADVANTA SST GRAFT (>_6MM)


Device Classification Name

prosthesis, vascular graft, of 6mm and greater diameter

510(k) Number K010516
Device Name ADVANTA SST GRAFT (>_6MM)
Original Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson, 
NH 
03051

Original Contact karen hall
Regulation Number 870.3450
Classification Product Code
DSY  
Date Received 02/22/2001
Decision Date 05/18/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls