HSA · registration DE0504291Vascular Solutions R350™ Guidewire
SingaporeCardiovascularClass DVascular Solutions LLC
Official record identity
- Registration number
- DE0504291
- Model name
- R350™ Guidewire
- Model identifier
- 7390
- Registration date
- March 30, 2020
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Vascular Solutions LLC
- Registrant / registration holder
- TELEFLEX MEDICAL ASIA PTE. LTD.
Official description
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
Additional source fields
- Product owner address
- 6464 Sycamore Court North, Minneapolis, Minnesota, 55369, United States
- Registrant address
- 83 CLEMENCEAU AVENUE, #05-05-08, UE SQUARE, Singapore 239920
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.