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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K860699
Device Name RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES
Applicant
Intracath, Inc.
14906 Newport Ave.
Suite H
Tustin,  CA  92680
Applicant Contact WENDELL V EBLING
Correspondent
Intracath, Inc.
14906 Newport Ave.
Suite H
Tustin,  CA  92680
Correspondent Contact WENDELL V EBLING
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/25/1986
Decision Date 04/02/1986
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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