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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 Less Then 6mm Diameter
510(k) Number K944844
Device Name BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
Applicant
Baxter Healthcare Corp
17221 Red Hill Ave.
Irvine,  CA  92714
Applicant Contact ESTHER SALTZ
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
Irvine,  CA  92714
Correspondent Contact ESTHER SALTZ
Regulation Number870.3450
Classification Product Code
DYF  
Date Received09/30/1994
Decision Date 03/31/1995
Decision SE - Postmarket Surveillance Required (SESP)
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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