PASSEO-35 - COFEPRIS Registration 580C2019 SSA
Access comprehensive regulatory information for PASSEO-35 (PASSEO-35) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 580C2019 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.
EL CATÉTER DE DILATACIÓN PERIFÉRICO PASSEO-35 ESTÁ INDICADO PARA DILATAR ESTENOSIS DE LAS ARTERIAS RENALES, ILIACAS, FEMORALES, POPLÍTEAS E INFRAPOPLÍTEAS, Y PARA EL TRATAMIENTO DE LESIONES OBSTRUCTIVAS DE FISTULAS ARTERIOVENOSAS DE DIÁLISIS NATIVAS O SIN
THE PASSEO-35 PERIPHERAL DILATION CATHETER IS INDICATED FOR DILATING STENOSIS OF THE RENAL, ILIAC, FEMORAL, POPLITEAL AND INFRAPOPLITEAL ARTERIES, AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR NO DIALYSIS ARTERIOVENOUS FISTULAS.