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IVASCULAR LUMINOR 35. ATP Balloon Dilation Catheter with Paclitaxel Release for 0.035 Inch Wire Guide - ARCSA Registration 1658dfc6f6d93bc40c9c314f22e55fdc

Access comprehensive regulatory information for IVASCULAR LUMINOR 35. ATP Balloon Dilation Catheter with Paclitaxel Release for 0.035 Inch Wire Guide in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID 1658dfc6f6d93bc40c9c314f22e55fdc and manufactured by LIFE VASCULAR DEVICE BIOTECH S.L. (LVDB). The device was registered on February 28, 2023.

This page provides complete registration details including product type (Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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ARCSA Official Data
IV
1658dfc6f6d93bc40c9c314f22e55fdc
IVASCULAR LUMINOR 35. ATP Balloon Dilation Catheter with Paclitaxel Release for 0.035 Inch Wire Guide
ARCSA ID: 1658dfc6f6d93bc40c9c314f22e55fdc
Local name: IVASCULAR LUMINOR 35. Catรฉter balรณn de dilataciรณn para ATP, con liberaciรณn de Paclitaxel, para guรญa de alambre 0.035 pulgadas
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
IVASCULAR
Commercial Name
Catheters
Registration Information
Analysis ID
1658dfc6f6d93bc40c9c314f22e55fdc
Registration Date
February 28, 2023
Expiration Date
February 28, 2028
Product Use

THE DEVICE IS INDICATED FOR THE DILATION OF STENOSIS LOCATED IN THE ILIAC, FEMORAL, ILIOFEMORAL, POPLITEA, INFRAPOPLITEAL AND RENAL ARTERIES, AS WELL AS FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF ORIGINAL OR ARTIFICIAL ARTERIOVENOUS FISTULAS, WHICH OCCUR WITH DIAMETERS BETWEEN 5 AND 7 MM AND LENGTHS FROM 20 TO 150 MM. IT IS ALSO INDICATED FOR THE POSTDILATION OF THE STENT IN THE PERIPHERAL VASCULAR SYSTEM.

Manufacturer
City
BARCELONA
Country
SPAIN
Address
ROAD TO CAN UBACH, 11.P.IND. LES FALLULLES, 08620 SANT VICENร‡ DELS HORTS, BARCELONA-SPAIN
Product Owner
Name
LIFE VASCULAR DEVICE BIOTECH S.L. (LVDB)
Country
SPAIN
Authorized Representative
Address
AV. EUGENIO ESPEJO, CONJUNTO VISTALBA S/N, VIA TANDA
Phone
22899256