Singapore HSA registration DE0502244
Stryker Neurovascular Trevo ProVue Retriever
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0502244
- Registration Date
- October 08, 2018
- Change Notification Approval Date
- September 02, 2024
- Retention Due Date
- October 07, 2025
Product description
It is indicated for use to restore blood flow in the neurovasculature by removing thrombus: - for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion (LVO), and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy should start within 6 hours of symptom onset. - for patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. - for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, LVO of the ICA or MCA-M1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age ≥80 years). Endovascular therapy should start within 6-24 hours of time last seen well in patients who are ineligible for IV t-PA or who fail IV t-PA therapy.
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)
- Trevo XP ProVue Retriever 4 x 20 Trevo XP ProVue Retriever 3 x 20 Trevo XP ProVue Retriever 4 x 30 Trevo XP ProVue Retriever 6 x 25 Trevo NXT ProVue Retriever 3x32 Trevo NXT ProVue Retriever 4x28 Trevo NXT ProVue Retriever 4x41 Trevo NXT ProVue Retriever 6x37
- Model Identifier(s)
- 90182 90183 90185 90186 90412 90413 90414 90415
About this record
Access comprehensive regulatory information for Stryker Neurovascular Trevo ProVue Retriever in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0502244 and owned by Stryker Neurovascular. The device was registered on October 08, 2018.
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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