Mexico COFEPRIS registration 581C2019 SSA

PASSEO-14

EN: PASSEO-14
Mexico flagMexico·Clase III·V. SURGICAL AND HEALING MATERIALS·LEVBETH MEDICAL, S.A. DE C.V.·Registered March 20, 2019
Product Use / Uso del Producto
Spanish

PASSEO-14 ESTÁ INDICADO PARA LA DILATACIÓN CON BALÓN DE LA PARTE ESTENÓTICA DE UNA ARTERIA DE LAS EXTREMIDADES INFERIORES, CON EL FIN DE MEJORAR LA PERFUSIÓN.

English

PASSEO-14 IS INDICATED FOR BALLOON DILATION OF THE STENOTIC PART OF AN ARTERY IN THE LOWER EXTREMITIES TO IMPROVE PERFUSION.

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)
CATÉTER DE DILATACIÓN PERIFÉRICO
Trade Name (English)
PERIPHERAL DILATION CATHETER
Registration information
Analysis ID
581C2019 SSA
Registration Date
March 20, 2019
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for PASSEO-14 (PASSEO-14) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 581C2019 SSA and manufactured by LEVBETH MEDICAL, S.A. DE C.V.. The device was registered on March 20, 2019.

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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