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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 K890182
Device Name PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
Applicant
Aesculap Instruments Corp.
3880 Blackhawk Dr.
Danville,  CA  94526
Applicant Contact DEAN A KNIGHT
Correspondent
Aesculap Instruments Corp.
3880 Blackhawk Dr.
Danville,  CA  94526
Correspondent Contact DEAN A KNIGHT
Regulation Number870.3450
Classification Product Code
DSY  
Date Received01/18/1989
Decision Date 02/28/1990
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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