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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 K933590
Device Name BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
Applicant
Baxter Healthcare Corp
Ewards Cvs Division
P.O. Box 11150
Santa Ana,  CA  92711
Applicant Contact Roberta Hines
Correspondent
Baxter Healthcare Corp
Ewards Cvs Division
P.O. Box 11150
Santa Ana,  CA  92711
Correspondent Contact Roberta Hines
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/26/1993
Decision Date 01/26/1994
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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