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Stryker Neurovascular AXS Catalyst™ Distal Access Catheter - HSA Registration DE0018180

Access comprehensive regulatory information for Stryker Neurovascular AXS Catalyst™ Distal Access Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0018180 and owned by Stryker Neurovascular. The device was registered on May 31, 2016.

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.

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CLASS D
DE0018180
Stryker Neurovascular AXS Catalyst™ Distal Access Catheter
HSA Registration Number: DE0018180
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Product Description

The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. It is also indicated for the removal/aspiration of soft emboli and thrombi from vessels in the peripheral and neurovasculature.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0018180
Registration Date
May 31, 2016
Change Notification Approval Date
September 21, 2023
Retention Due Date
May 30, 2025
Product Owner
Short Name
Stryker Neurovascular
Address
47900 Bayside Parkway, Fremont, CA 94538, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
AXS Catalyst 7 Distal Access Catheter 0.068 in x 115cm AXS Catalyst 7 Distal Access Catheter 0.068 in x 125cm AXS Catalyst 7 Distal Access Catheter 0.068 in x 132cm AXS Catalyst™ 5 AXS Catalyst™ 5 AXS Catalyst™ 6
Model Identifier(s)
IC068115A IC068125A IC068132A M003IC058115A0 M003IC058132A0 M003IC060132A0