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SHOCKWAVEMEDICALPERIPHERALINTRAVASCULAR LITHOTRIPSY (IVL)SYSTEM: S4 PERIPHERALINTRAVASCULAR LIT - COFEPRIS Registration 116C2021 SSA

Access comprehensive regulatory information for SHOCKWAVEMEDICALPERIPHERALINTRAVASCULAR LITHOTRIPSY (IVL)SYSTEM: S4 PERIPHERALINTRAVASCULAR LIT (SHOCKWAVEMEDICALPERIPHERALINTRAVASCULAR LITHOTRIPSY (IVL)SYSTEM: S4 PERIPHERALINTRAVASCULAR LIT) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 116C2021 SSA and manufactured by MEDSTENT, S.A. DE C.V.. The device was registered on February 02, 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
116C2021 SSA
SHOCKWAVEMEDICALPERIPHERALINTRAVASCULAR LITHOTRIPSY (IVL)SYSTEM: S4 PERIPHERALINTRAVASCULAR LIT
COFEPRIS Analysis ID: 116C2021 SSA
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Product Use / Uso del Producto
Spanish

EL CATÉTER DE LITOTRICIA INTRAVASCULAR(IVL) PERIFÉRICA S4 DE SHOCKWAVEMEDICAL, INC. ES UN DISPOSITIVO DELITOTRICIA ADMINISTRADO A TRAVÉS DELSISTEMA ARTERIAL PERIFÉRICO DE LASEXTREMIDADES INFERIORES EN UNA ZONADE ESTENOSIS CALCIFICADA QUE, DE OTRAMANERA,RESULTARÍACOMPLICADOTRATAR.LA ACTIVACIÓN DEL DISPOSITIVO DELITOTRICIA GENERA ENERGÍA MECÁNICAPULSÁTIL EN LA ZONA DE TRATAMIENTOOBJETIVO,ROMPEELCALCIOENLALESIÓNYPERMITELADILATACIÓNPOSTERIORDEUNAESTENOSIS ARTERIAL PERIFÉR

English

THE SHOCKWAVEMEDICAL, INC. S4 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER IS A CRIMETRICIAN DEVICE DELIVERED THROUGH THE PERIPHERAL ARTERIAL SYSTEM OF THE LOWER EXTREMITIES INTO AN OTHERWISE DIFFICULT AREA OF CALCIFIED STENOSIS. THE ACTIVATION OF THE DELITOTRICIA DEVICE GENERATES PULSATILE MECHANICAL ENERGY IN THE TARGET TREATMENT AREA, ROMPEELCALCIUM IN THE LESION AND ALLOWS POSTERIOR DILATION OF A PERIPHERIC ARTERIAL STENOSIS

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 PERCUTÁNEO
Trade Name (English)
PERCUTANEOUS CATHETER
Registration Information
Analysis ID
116C2021 SSA
Registration Date
February 02, 2021
Manufacturer / Fabricante
Name (English)
MEDSTENT, S.A. DE C.V.