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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 K981076
Device Name VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
Applicant
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Applicant Contact KRISTI M KISTNER
Correspondent
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Correspondent Contact KRISTI M KISTNER
Regulation Number870.3450
Classification Product Code
DYF  
Date Received03/24/1998
Decision Date 05/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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