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MICROCATÉTER HEADWAY DUO - COFEPRIS Registration 359C2020 SSA

Access comprehensive regulatory information for MICROCATÉTER HEADWAY DUO (MICROCATÉTER HEADWAY DUO) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 359C2020 SSA and manufactured by LEVBETH MEDICAL, S.A. DE C.V.. The device was registered on March 23, 2020.

This page provides complete registration details including product type (V. SURGICAL AND HEALING MATERIALS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase III
359C2020 SSA
MICROCATÉTER HEADWAY DUO
COFEPRIS Analysis ID: 359C2020 SSA
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Product Use / Uso del Producto
Spanish

EL MICROCATÉTER HEADWAY DUO ESTÁDISEÑADO PARA USO INTRAVASCULARGENERAL, INCLUIDA LA VASCULATURAPERIFÉRICA YCORONARIA PARA LA INFUSIÓNDEAGENTESDEDIAGNÓSTICO,COMOMEDIOSDE CONTRASTE Y AGENTES TERAPÉUTICOS,COMO MATERIALESDEEMBOLIZACIÓNYQUEHAN SIDO APROBADOS PARA SU USO ENNEUROVASCULATURA Y SON COMPATIBLESCON EL DIÁMETRO INTERNO DELMICROCATÉTER. ELMICROCATÉTERHEADWAYDUO ES UN CATÉTER DE UNA SOLA LUZDISEÑADO PARA INTRODUCIRSE SOBRE UNAGUÍA METÁLICA DIRIGIBLE.

English

THE HEADWAY DUO MICROCATHETER IS DESIGNED FOR GENERAL INTRAVASCULAR USE, INCLUDING PERIPHERAL AND CORONARY VASCULATURE FOR THE INFUSION OF DIAGNOSTIC AGENTS, SUCH AS CONTRAST MEDIA AND THERAPEUTIC AGENTS, SUCH AS EMBOLIZATION MATERIALS, AND WHICH HAVE BEEN APPROVED FOR USE IN NEUROVASCULATURE AND ARE COMPATIBLE WITH THE INTERNAL DIAMETER OF THE MICROCATHETER. THE HEADWAYDUO MICROCATHETER IS A SINGLE-LUMEN CATHETER DESIGNED TO BE INSERTED OVER A STEERABLE METAL GUIDE.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
V. MATERIALES QUIRÚRGICOS Y DE CURACIÓN
Product Type (English)
V. SURGICAL AND HEALING MATERIALS
Trade Name (Spanish)
MICROCATÉTER
Trade Name (English)
MICROCATÉTER
Registration Information
Analysis ID
359C2020 SSA
Registration Date
March 23, 2020
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL, S.A. DE C.V.