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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 K004012
Device Name IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
Applicant
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Applicant Contact LORRI CHAVEZ
Correspondent
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Correspondent Contact LORRI CHAVEZ
Regulation Number870.3450
Classification Product Code
DYF  
Date Received12/27/2000
Decision Date 05/14/2001
Decision Substantially Equivalent (SESE)
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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