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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K821488
Device Name ELECATH PORTAL VEIN/BILIARY DRAIN ASSM
Applicant
Electro-Catheter Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Electro-Catheter Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3920
Classification Product Code
KNN  
Date Received05/18/1982
Decision Date 05/28/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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