SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS


codes

Device Classification Name

prosthesis, vascular graft, of 6mm and greater diameter

510(k) Number K002007
Device Name SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
Original Applicant
SULZER CARBOMEDICS, INC.
1300 east anderson ln.
austin, 
TX 
78752

Original Contact lisa o’conner
Regulation Number 870.3450
Classification Product Code
DSY  
Date Received 07/03/2000
Decision Date 01/25/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No