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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 K843500
Device Name FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN
Applicant
Cardio-Vascular Innovations, Inc.
P.O. Box 268
Chantilly,  VA  22021
Applicant Contact DANIEL W SAWYER
Correspondent
Cardio-Vascular Innovations, Inc.
P.O. Box 268
Chantilly,  VA  22021
Correspondent Contact DANIEL W SAWYER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/06/1984
Decision Date 10/18/1984
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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