Singapore HSA registration DE0018180
Stryker Neurovascular AXS Catalyst™ Distal Access Catheter
Singapore·CLASS D·Stryker Neurovascular·Registered May 31, 2016Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D