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Singapore HSA registration DE0505475

Micro Therapeutics Medtronic Solitaire X Revascularization Device

Singapore flagSingapore·CLASS D·Micro Therapeutics, Inc. d/b/a ev3 Neurovascular·Registered February 17, 2021
Device classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0505475
Registration Date
February 17, 2021
Change Notification Approval Date
October 06, 2023
Retention Due Date
February 16, 2026
Product description
The Solitaire™ X Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Solitaire™ X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke
Product Owner
Name
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Short Name
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Address
9775 Toledo Way, Irvine CA 92618, UNITED STATES, UNITED STATES
Registrant
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device Solitaire™ X Revascularization Device
Model Identifier(s)
SFR4-3-20-10 SFR4-3-40-10 SFR4-4-20-05 SFR4-4-20-10 SFR4-4-40-10 SFR4-6-20-10 SFR4-6-24-06 SFR4-6-40-10
About this record

Access comprehensive regulatory information for Micro Therapeutics Medtronic Solitaire X Revascularization Device in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505475 and owned by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device was registered on February 17, 2021.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D