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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 K971897
Device Name CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
Applicant
Medron, Inc.
3614 W. 2100 S.
Salt Lake City,  UT  84120
Applicant Contact RON WORTLEY
Correspondent
Medron, Inc.
3614 W. 2100 S.
Salt Lake City,  UT  84120
Correspondent Contact RON WORTLEY
Regulation Number876.5540
Classification Product Code
LFK  
Subsequent Product Code
FKA  
Date Received05/22/1997
Decision Date 10/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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