Singapore HSA registration DE0509514
BARD BD Highlander™ 014 PTA Balloon Dilatation Catheter
Singapore·CLASS B·Bard Peripheral Vascular, Inc·Registered July 11, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0509514
- Registration Date
- July 11, 2024
- Change Notification Approval Date
- December 02, 2024
- Retention Due Date
- July 10, 2025
Product description
The Highlander™ 014 PTA Balloon Dilatation Catheter is indicated for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal, infra-popliteal, and renal arteries. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.
Product Owner
- Short Name
- Bard
- Address
- 1625 West 3rd Street, Tempe, AZ 85281, UNITED STATES
Registrant
- Address
- 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
- Address
- 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
- Model Name(s)
- Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter Highlander 014 PTA Balloon Dilatation Catheter
- Model Identifier(s)
- H4150210 H4150212 H4150215 H415022 H415024 H415026 H415028 H41502H10 H41502H12 H41502H15 H41502H2 H41502H4 H41502H6 H41502H8 H4150310 H4150312 H4150315 H415032 H415034 H415036 H415038 H41503H10 H41503H12 H41503H15 H41503H2 H41503H4 H41503H6 H41503H8 H4150410 H4150412 H4150415 H415042 H415044 H415046 H415048
About this record
Access comprehensive regulatory information for BARD BD Highlander™ 014 PTA Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509514 and owned by Bard Peripheral Vascular, Inc. The device was registered on July 11, 2024.
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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