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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 K911184
Device Name SCANLAN/TAHERI VALVULOTOME
Applicant
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Applicant Contact KENNETH R BLAKE
Correspondent
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Correspondent Contact KENNETH R BLAKE
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received03/18/1991
Decision Date 02/18/1992
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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