MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

Catheter, Hemodialysis, Triple Lumen, Non-implanted

COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA

The following data is part of a premarket notification filed by Covidien Llc, Formerly Registered As Tyco Healthca with the FDA for Mahurkar Triple Lumen Dialysis Catheter.

Pre-market Notification Details

Device IDK102605
510k NumberK102605
Device Name:MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
ClassificationCatheter, Hemodialysis, Triple Lumen, Non-implanted
Applicant COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactDaniel Campion
CorrespondentDaniel Campion
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeNIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-10
Decision Date2010-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40884521128010 K102605 000
20884521128139 K102605 000
20884521128122 K102605 000
20884521128115 K102605 000
20884521128092 K102605 000
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20884521128160 K102605 000
20884521128108 K102605 000
30884521127993 K102605 000
20884521128146 K102605 000
20884521128184 K102605 000
30884521128006 K102605 000
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20884521128030 K102605 000
20884521128023 K102605 000
10884521128002 K102605 000
10884521127999 K102605 000
10884521127890 K102605 000

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