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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K935349
Device Name LOCALMED INFUSION CATHETER
Applicant
Localmed, Inc.
552 Del Rey Ave.
Sunnyvale,  CA  94086
Applicant Contact AARON V KAPLAN
Correspondent
Localmed, Inc.
552 Del Rey Ave.
Sunnyvale,  CA  94086
Correspondent Contact AARON V KAPLAN
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/05/1993
Decision Date 10/18/1994
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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