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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Femoral
510(k) Number K914936
Device Name CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
Applicant
Akcess Medical Products, Inc.
201 N. Center Dr.
New Brunswick,  NJ  08902
Applicant Contact BALBIR B KAPANY
Correspondent
Akcess Medical Products, Inc.
201 N. Center Dr.
New Brunswick,  NJ  08902
Correspondent Contact BALBIR B KAPANY
Regulation Number876.5540
Classification Product Code
LFK  
Date Received11/04/1991
Decision Date 04/23/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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