Pure Global AI
HSA · registration DE0508898

Medtronic Radiant™ Balloon-Expandable Covered Stent

SingaporeGeneral HospitalClass DMedtronic, Inc
Official record identity
Registration number
DE0508898
Model name
Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent; Radiant™ Balloon-Expandable Covered Stent
Model identifier
RBXCS622120EE; RBXCS632120EE; RBXCS638120EE; RBXCS659120EE; RBXCS722120EE; RBXCS732120EE; RBXCS738120EE; RBXCS759120EE
Registration date
January 26, 2024
Classification
Risk class
Class D
Official value: CLASS D
Published category
General Hospital
Published parties
Product owner
Medtronic, Inc
Official description

The Radiant balloon-expandable covered stent system is intended to maintain perfusion to the renal arteries when used in combination with the Endurant II/IIs stent graft system. The devices are used together to repair juxtarenal abdominal aortic or aortoiliac aneurysms with a parallel graft technique in an endovascular approach. This is accomplished by providing an alternative conduit for blood flow within the patient’s vessel (aorta, iliac, and renal arteries) by excluding the aneurysm (target lesion).

Additional source fields
Product owner address
710 Medtronic Parkway, Minneapolis, MN 55432, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.