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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K865017
Device Name ANGIOSCOPE
Applicant
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact BRUCE BEAUCHEMIN
Correspondent
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact BRUCE BEAUCHEMIN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/23/1986
Decision Date 12/15/1987
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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