FDA 510(k)

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

K-Number: K110793 · 2011-12-16

Decision Date2011-12-16

Product CodeMPB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS is the device name listed in this FDA 510(k) record. The listed applicant is Ameco Medical Industries. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K110793. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS?

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Ameco Medical Industries. The 510(k) number is K110793.

When did AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS receive FDA 510(k) clearance?

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS received FDA 510(k) clearance on 2011-12-16, under 510(k) number K110793.

Who is the listed applicant for AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS?

The FDA 510(k) record lists Ameco Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS?

The FDA product code for AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS is MPB.

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Other records listing Ameco Medical Industries as applicant

K152819Amecath Peripheral inserted Central Venous Catheter Sets K131144AMECO SHEATH INTRODUCER K131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER K123943AMECATH DUAL LUMEN HEMODIALYSIS CATHETER K110794AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS

Related Devices (Code: MPB)

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated

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.