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Reprocessed Daig Livewire Electrophysiology Catheters

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052603

by Alliance Medical, Inc.

Identifiers

510(k) Number
K052603 FDA 510(k)
FDA Product Code
NLH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1220 FDA 510(k)
Regulation Number
870.1220 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a reprocessed catheter designed for recording electrophysiological signals. It is classified as a Catheter, Recording, Electrode, Reprocessed under product code NLH and is intended for cardiovascular applications.

The device is supplied in a reprocessed condition and has received FDA 510(k) clearance (K052603) as substantially equivalent to a predicate device. It is a Class II medical device subject to special controls and is manufactured by Alliance Medical Corp. in Phoenix, Arizona.

Frequently asked questions

What is the REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS used for?

This device is designed for recording electrophysiological signals in cardiovascular applications, as indicated by its product code NLH and classification as a Catheter, Recording, Electrode, Reprocessed.

How is the REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS supplied and is it sterile?

The device is supplied in a reprocessed condition, meaning it has been cleaned, disinfected, inspected, repackaged, and released for reuse after prior clinical use, following validated reprocessing procedures to ensure it is safe for patient use.

What regulatory pathway was used for the REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS?

The device received FDA 510(k) clearance under K052603, demonstrating it is substantially equivalent to a legally marketed predicate device, and is regulated as a Class II medical device with special controls.

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: K052603 FDA 510(k) - REPROCESSED DAIG LIVEWIRE ELECTROPHYSIO..., Reprocessed Daig Livewire Electrophysiology Catheters, Reprocessed Daig Livewire Electrophysiology Catheters 510 (k) FDA ..., PDF K052603 Reprocessed Daig Livewire Electrophysiology Catheters, Daig Livewire Steerable Reprocessed Electrophysiology Catheters ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alliance Medical, Inc.
FDA Applicant
Alliance Medical Corp.

Sources (1)

  • FDA 510(k) K052603 24 fields · synced Oct 6, 2026