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Stryker Neurovascular AXS Vecta® Intermediate Catheter - HSA Registration DE0507662

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.

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CLASS D
DE0507662
Stryker Neurovascular AXS Vecta® Intermediate Catheter
HSA Registration Number: DE0507662
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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.

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 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