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ANGIOSCULPT® PTA SCORINGBALLOON CATHETER - COFEPRIS Registration 813C2021 SSA

Access comprehensive regulatory information for ANGIOSCULPT® PTA SCORINGBALLOON CATHETER (ANGIOSCULPT® PTA SCORINGBALLOON CATHETER) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 813C2021 SSA and manufactured by MEDSTENT, S.A. DE C.V.. The device was registered on July 05, 2021.

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
813C2021 SSA
ANGIOSCULPT® PTA SCORINGBALLOON CATHETER
COFEPRIS Analysis ID: 813C2021 SSA
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Product Use / Uso del Producto
Spanish

ANGIOSCULPT PTA SCORING BALLOONCATHETER ESTÁ INDICADO PARADILATACIONES POR BALÓN DE ARTERIASPERIFÉRICAS COMO ILIACA, FEMORAL, ILIO-FEMORAL, POPLÍTEA, INFRA POPLÍTEA,ARTERIASRENALESYPARAELTRATAMIENTODELESIONESOBSTRUCTIVASDEFÍSTULASDEDIÁLISIS ARTERIOVENOSAS NATURALES OSINTÉTICAS. NO ESTÁ INDICADO PARA ELUSO EN NEUROVASCULATURA CORONARIA.

English

ANGIOSCULPT PTA SCORING BALLOONCATHETER IS INDICATED FOR BALLOON DILATIONS OF PERIPHERAL ARTERIES SUCH AS ILIAC, FEMORAL, ILIO-FEMORAL, POPLITEAL, INFRAPOPLITEAL, RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONSNATURAL OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAS. IT IS NOT INDICATED FOR USE IN CORONARY NEUROVASCULATURE.

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)
CATÉTERCONBALÓNPARAANGIOPLASTIAPERIFÉRICA, BÁSICO
Trade Name (English)
BALLOON CATHETERPARAANGIOPLASTY, BASIC
Registration Information
Analysis ID
813C2021 SSA
Registration Date
July 05, 2021
Manufacturer / Fabricante
Name (English)
MEDSTENT, S.A. DE C.V.