Singapore HSA registration DE0507662
Stryker Neurovascular AXS Vecta® Intermediate Catheter
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0507662
- Registration Date
- January 06, 2023
- Change Notification Approval Date
- November 01, 2024
- Retention Due Date
- January 05, 2026
Product description
The Stryker Neurovascular AXS Vecta® Intermediate 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. The Stryker Neurovascular AXS Vecta® Intermediate Catheter is also indicated for use as a conduit for retrieval devices. The Stryker Neurovascular AXS Vecta® Intermediate Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
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
Model information
- Model Name(s)
- AXS Vecta 71 Intermediate Catheter – 115 cm AXS Vecta 71 Intermediate Catheter – 125 cm AXS Vecta 71 Intermediate Catheter – 132 cm AXS Vecta 74 Intermediate Catheter – 115 cm AXS Vecta 74 Intermediate Catheter – 125 cm AXS Vecta 74 Intermediate Catheter – 132 cm
- Model Identifier(s)
- INC-11129-115 INC-11129-125 INC-11129-132 INC-11597-115 INC-11597-125 INC-11597-132
About this record
Access comprehensive regulatory information for Stryker Neurovascular AXS Vecta® Intermediate 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 DE0507662 and owned by Stryker Neurovascular. The device was registered on January 06, 2023.
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