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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 K050049
Device Name DYNAFLO BYPASS GRAFT
Applicant
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact GLENN NORTON
Correspondent
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact GLENN NORTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received01/10/2005
Decision Date 01/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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