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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K954234
Device Name RADIFOCUS INTRODUCER II KIT
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact KEITH SMITH
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact KEITH SMITH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/11/1995
Decision Date 11/27/1995
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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