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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 K004011
Device Name IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
Applicant
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Applicant Contact LORI CHAVEZ
Correspondent
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Correspondent Contact LORI CHAVEZ
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/27/2000
Decision Date 03/27/2001
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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