Pure Global

Stealth 360™ Peripheral Orbital Atherectomy System - FDA Registration CMDR-2025-05157

Access comprehensive regulatory information for Stealth 360™ Peripheral Orbital Atherectomy System in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number CMDR-2025-05157 and manufactured by Cardiovascular Systems, Inc. - 1225 Old Highway 8 NW, St. Paul, MN 55112 USA in USA. The device was registered on July 14, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Abbott Laboratories), 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.

Free Database
Powered by Pure Global AI
FDA Official Data
USA
CMDR-2025-05157
Stealth 360™ Peripheral Orbital Atherectomy System
Registered medical device in Philippines
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Product Name
Stealth 360™ Peripheral Orbital Atherectomy System
Registration Number
CMDR-2025-05157
Manufacturer Details
Importer & Distribution
Importer/Distributor
Abbott Laboratories
Registration Dates
Issuance Date
July 14, 2025
Expiry Date
July 14, 2030