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Multitrack Angiographic Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003902

by NuMED, Inc.

Identifiers

510(k) Number
K003902 FDA 510(k)
FDA Product Code
DQO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1200 FDA 510(k)
Regulation Number
870.1200 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Multi-Track Angiographic Catheter is a diagnostic catheter designed for angiography and pressure measurements during cardiac catheterization procedures. Its unique guidewire placement enhances flow rate and maneuverability, facilitating precise imaging and interventions in pediatric and adult patients.

This device is supplied in French sizes ranging from 3.0 to 6.0 FR with usable lengths of either 80 cm or 100 cm. Constructed from radiopaque materials, it ensures visibility under fluoroscopy. The catheter is intended for single-use applications in cardiac catheterization labs and has received FDA 510(k) clearance under the Special 510(k) pathway for substantial equivalence in the Cardiovascular category.

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: Multi-Track™ Angiographic Catheter | NuMED For Children, Multi-Track™ Angiographic Catheters - bisusa.com, MULTI-TRACK™ Angiographic catheter - Ameesa Medical, Multi-Track™ Angiographic Catheter | NuMED For Children

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
NuMED, Inc.

Sources (1)

  • FDA 510(k) K003902 24 fields · synced Sep 18, 2026