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Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110793

by Ameco Medical Industries

Identifiers

510(k) Number
K110793 FDA 510(k)
FDA Product Code
MPB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5540 FDA 510(k)
Regulation Number
876.5540 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Amecath and Amecath Uniqath Soft are short-term dual hemodialysis catheterization kits. These devices consist of a catheter assembly designed to provide blood access during acute hemodialysis and apheresis procedures.

The catheter is inserted percutaneously, with the internal jugular vein identified as the preferred placement site. This device is a Class 2 non-implanted hemodialysis catheter that received FDA 510(k) clearance under K110793.

Frequently asked questions

What are the Amecath and Amecath Uniqath Soft kits used for?

These kits are designed to provide temporary blood access for patients requiring acute hemodialysis or apheresis procedures. They are intended for percutaneous insertion, with the internal jugular vein being the preferred site for placement.

What is the regulatory status of these hemodialysis catheters?

These devices are classified as Class 2 non-implanted hemodialysis catheters. They have received FDA 510(k) clearance under submission number K110793, which determined the devices to be substantially equivalent to existing predicate devices.

Are these catheters intended for long-term use?

No, these are specifically designated as short-term hemodialysis catheterization kits. They are intended for acute clinical scenarios rather than long-term or chronic indwelling applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis ..., amecath and amecath uniqath soft short term dual hemodialysis ..., K110793 FDA 510(k) - AMECATH AND AMECATH UNIQATH SOFT SHORT ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ameco Medical Industries

Sources (1)

  • FDA 510(k) K110793 24 fields · synced Oct 6, 2026