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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Triple Lumen, Non-Implanted
510(k) Number K102605
Device Name MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
Applicant
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact Daniel Campion
Correspondent
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact Daniel Campion
Regulation Number876.5540
Classification Product Code
NIE  
Date Received09/10/2010
Decision Date 12/22/2010
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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