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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 K922025
Device Name ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
Applicant
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact WRIGHT
Correspondent
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact WRIGHT
Regulation Number870.3450
Classification Product Code
DSY  
Date Received04/07/1992
Decision Date 09/22/1992
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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