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LEGFLOW OTW Paclitaxel Releasing Peripheral Balloon Dilatacion Catheter - ARCSA Registration 2f293cfa68686ba83d221433c0b8e6ee

Access comprehensive regulatory information for LEGFLOW OTW Paclitaxel Releasing Peripheral Balloon Dilatacion Catheter in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID 2f293cfa68686ba83d221433c0b8e6ee and manufactured by CARDIONOVUM GMBH. The device was registered on December 17, 2020.

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
2f293cfa68686ba83d221433c0b8e6ee
LEGFLOW OTW Paclitaxel Releasing Peripheral Balloon Dilatacion Catheter
ARCSA ID: 2f293cfa68686ba83d221433c0b8e6ee
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
CARDIONOVUM GmbH
Commercial Name
CATHETERS, VASCULAR, ANGIOPLASTY, BALLOON
Registration Information
Analysis ID
2f293cfa68686ba83d221433c0b8e6ee
Registration Date
December 17, 2020
Expiration Date
December 17, 2025
Product Use

IT IS INDICATED FOR TREATMENT (BY BALLOON DILATION) OF DE NOVO LESIONS AND RESTENOSIS IN PERIPHERAL ARTERIES: RENAL, ILIAC, FEMOROPOPLITEA (SUPERFICIAL FEMORAL AND POPLITEA), NATIVE LESIONS BELOW THE KNEE, INTRASTENT RESTENOSIS, LOWER EXTREMITY ISCHEMIA.

Manufacturer
City
BONN
Country
GERMANY
Address
AM BONNER BOGEN 2, 53227 BONN
Product Owner
Name
HEALTH SPHERE LLC
Country
UNITED STATES
Authorized Representative
Address
AV DE LOS SHYRIS N9-38 AND BELGICA STREET
Phone
23800917