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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 K843641
Device Name CATHETER INTRODUCER SYSTEM
Applicant
Xanmed Corp.
815 Connecticut Ave. Nw
Washington,  DC  20006
Applicant Contact DAVID B BANCEIE
Correspondent
Xanmed Corp.
815 Connecticut Ave. Nw
Washington,  DC  20006
Correspondent Contact DAVID B BANCEIE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/17/1984
Decision Date 10/23/1984
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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