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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K823758
Device Name CENTRAL VEIN CATHERIZATION KIT
Applicant
Access Devices, Inc.
Chadds Ford,  PA 
Correspondent
Access Devices, Inc.
Chadds Ford,  PA 
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/14/1982
Decision Date 02/23/1983
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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