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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 K962639
Device Name IMPRA CARBOFLO EPTFE VASCULAR GRAFT
Applicant
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Applicant Contact MARK GATERUD
Correspondent
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Correspondent Contact MARK GATERUD
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Code
DYF  
Date Received07/05/1996
Decision Date 10/03/1996
Decision SE - Postmarket Surveillance Required (SESP)
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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