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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K002007
Device Name SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
Applicant
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact LISA O'CONNER
Correspondent
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact LISA O'CONNER
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/03/2000
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
Predetermined Change
Control Plan Authorized		 No
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