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Fusion® Quattro® Extraction Balloon - FDA Registration MDR-06654

Access comprehensive regulatory information for Fusion® Quattro® Extraction Balloon in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-06654 and manufactured by Wilson Cook Medical, Inc. - 4900 Bethania Station Road, Winston-Salem, North Carolina, USA in USA. The device was registered on June 10, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Macare Medicals, Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.

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MDR-06654
Fusion® Quattro® Extraction Balloon
Registered medical device in Philippines
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Device Information
Product Name
Fusion® Quattro® Extraction Balloon
Registration Number
MDR-06654
Importer & Distribution
Importer/Distributor
Macare Medicals, Inc.
Registration Dates
Issuance Date
June 10, 2025
Expiry Date
April 13, 2029