Singapore HSA registration DE0504409

Stryker Neurovascular Surpass Evolve Flow Diverter System

Singapore·CLASS D·Stryker Neurovascular·Registered April 29, 2020

Device classification

Device Class: CLASS D
Medical Speciality Area: Neurology

Registration information

Registration Number: DE0504409
Registration Date: April 29, 2020
Change Notification Approval Date: September 11, 2023
Retention Due Date: April 28, 2026

Product description

The flow diverter is intended to divert blood flow from entering an aneurysm sac from the parent artery. The Surpass Evolve Flow Diverter System is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥2.0mm and ≤5.0mm.

Product Owner

Name: Stryker Neurovascular
Short Name: Stryker Neurovascular
Address: 47900 Bayside Parkway, Fremont, CA 94538, UNITED STATES

Registrant

Name: STRYKER SINGAPORE PRIVATE LIMITED
Address: 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Importer

Name: STRYKER SINGAPORE PRIVATE LIMITED TRANSMEDIC PTE LTD
Address: 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): Surpass Evolve Flow Diverter System (2.5mm x 12mm) Surpass Evolve Flow Diverter System (2.5mm x 13mm) Surpass Evolve Flow Diverter System (2.5mm x 14mm) Surpass Evolve Flow Diverter System (2.5mm x 15mm) Surpass Evolve Flow Diverter System (2.5mm x 16mm) Surpass Evolve Flow Diverter System (2.5mm x 17mm) Surpass Evolve Flow Diverter System (2.5mm x 18mm) Surpass Evolve Flow Diverter System (2.5mm x 19mm) Surpass Evolve Flow Diverter System (2.5mm x 20mm) Surpass Evolve Flow Diverter System (3.25mm x 12mm) Surpass Evolve Flow Diverter System (3.25mm x 13mm) Surpass Evolve Flow Diverter System (3.25mm x 14mm) Surpass Evolve Flow Diverter System (3.25mm x 15mm) Surpass Evolve Flow Diverter System (3.25mm x 16mm) Surpass Evolve Flow Diverter System (3.25mm x 17mm) Surpass Evolve Flow Diverter System (3.25mm x 18mm) Surpass Evolve Flow Diverter System (3.25mm x 19mm) Surpass Evolve Flow Diverter System (3.25mm x 20mm) Surpass Evolve Flow Diverter System (3.25mm x 21mm) Surpass Evolve Flow Diverter System (3.25mm x 22mm) Surpass Evolve Flow Diverter System (3.25mm x 25mm) Surpass Evolve Flow Diverter System (3.25mm x 30mm) Surpass Evolve Flow Diverter System (4.0mm x 12mm) Surpass Evolve Flow Diverter System (4.0mm x 13mm) Surpass Evolve Flow Diverter System (4.0mm x 14mm) Surpass Evolve Flow Diverter System (4.0mm x 15mm) Surpass Evolve Flow Diverter System (4.0mm x 16mm) Surpass Evolve Flow Diverter System (4.0mm x 17mm) Surpass Evolve Flow Diverter System (4.0mm x 18mm) Surpass Evolve Flow Diverter System (4.0mm x 19mm) Surpass Evolve Flow Diverter System (4.0mm x 20mm) Surpass Evolve Flow Diverter System (4.0mm x 21mm) Surpass Evolve Flow Diverter System (4.0mm x 22mm) Surpass Evolve Flow Diverter System (4.0mm x 25mm) Surpass Evolve Flow Diverter System (4.0mm x 30mm) Surpass Evolve Flow Diverter System (4.0mm x 40mm) Surpass Evolve Flow Diverter System (4.5mm x 12mm) Surpass Evolve Flow Diverter System (4.5mm x 13mm) Surpass Evolve Flow Diverter System (4.5mm x 14mm) Surpass Evolve Flow Diverter System (4.5mm x 15mm) Surpass Evolve Flow Diverter System (4.5mm x 16mm) Surpass Evolve Flow Diverter System (4.5mm x 17mm) Surpass Evolve Flow Diverter System (4.5mm x 18mm) Surpass Evolve Flow Diverter System (4.5mm x 19mm) Surpass Evolve Flow Diverter System (4.5mm x 20mm) Surpass Evolve Flow Diverter System (4.5mm x 21mm) Surpass Evolve Flow Diverter System (4.5mm x 22mm) Surpass Evolve Flow Diverter System (4.5mm x 25mm) Surpass Evolve Flow Diverter System (4.5mm x 30mm) Surpass Evolve Flow Diverter System (4.5mm x 40mm) Surpass Evolve Flow Diverter System (5.0mm x 12mm) Surpass Evolve Flow Diverter System (5.0mm x 13mm) Surpass Evolve Flow Diverter System (5.0mm x 14mm) Surpass Evolve Flow Diverter System (5.0mm x 15mm) Surpass Evolve Flow Diverter System (5.0mm x 16mm) Surpass Evolve Flow Diverter System (5.0mm x 17mm) Surpass Evolve Flow Diverter System (5.0mm x 18mm) Surpass Evolve Flow Diverter System (5.0mm x 19mm) Surpass Evolve Flow Diverter System (5.0mm x 20mm) Surpass Evolve Flow Diverter System (5.0mm x 21mm) Surpass Evolve Flow Diverter System (5.0mm x 22mm) Surpass Evolve Flow Diverter System (5.0mm x 25mm) Surpass Evolve Flow Diverter System (5.0mm x 30mm) Surpass Evolve Flow Diverter System (5.0mm x 40mm)
Model Identifier(s): FD25012 FD25013 FD25014 FD25015 FD25016 FD25017 FD25018 FD25019 FD25020 FD32512 FD32513 FD32514 FD32515 FD32516 FD32517 FD32518 FD32519 FD32520 FD32521 FD32522 FD32525 FD32530 FD40012 FD40013 FD40014 FD40015 FD40016 FD40017 FD40018 FD40019 FD40020 FD40021 FD40022 FD40025 FD40030 FD40040 FD45012 FD45013 FD45014 FD45015 FD45016 FD45017 FD45018 FD45019 FD45020 FD45021 FD45022 FD45025 FD45030 FD45040 FD50012 FD50013 FD50014 FD50015 FD50016 FD50017 FD50018 FD50019 FD50020 FD50021 FD50022 FD50025 FD50030 FD50040

About this record

Access comprehensive regulatory information for Stryker Neurovascular Surpass Evolve Flow Diverter System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504409 and owned by Stryker Neurovascular. The device was registered on April 29, 2020.

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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