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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 K890766
Device Name CATHETER INTRODUCER SHEATH
Applicant
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Applicant Contact JOHN GEHRICH
Correspondent
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Correspondent Contact JOHN GEHRICH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/15/1989
Decision Date 09/18/1989
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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