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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K932009
Device Name THE SAMUELS RETROGRAD VALVULOTOME
Applicant
Vascutech, Inc.
790 Tpke. St.
North Andover,  MA  01845
Applicant Contact GEORGE W LEMAITRE
Correspondent
Vascutech, Inc.
790 Tpke. St.
North Andover,  MA  01845
Correspondent Contact GEORGE W LEMAITRE
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received04/23/1993
Decision Date 09/21/1993
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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