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FDA 510(k)

MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

K-Number: K102605 · 2010-12-22

ApplicantCovidien, LLC, Formerly Registered AS Tyco Healthca
Decision Date2010-12-22
Product CodeNIE
Advisory CommitteeGU
DecisionUnknown

Device Summary

MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC, Formerly Registered AS Tyco Healthca. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K102605. The device is classified under product code NIE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER?

MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Covidien, LLC, Formerly Registered AS Tyco Healthca. The 510(k) number is K102605.

When did MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER receive FDA 510(k) clearance?

MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER received FDA 510(k) clearance on 2010-12-22, under 510(k) number K102605.

Who is the listed applicant for MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER?

The FDA 510(k) record lists Covidien, LLC, Formerly Registered AS Tyco Healthca as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER?

The FDA product code for MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER is NIE.

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Other records listing Covidien, LLC, Formerly Registered AS Tyco Healthca as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NIE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International CorporationK183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp)K123292T3MedcompK083675POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETERC.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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