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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 K944858
Device Name BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
Applicant
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614
Applicant Contact ESTHER SALTZ
Correspondent
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614
Correspondent Contact ESTHER SALTZ
Regulation Number870.3450
Classification Product Code
DSY  
Date Received10/03/1994
Decision Date 01/05/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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