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Singapore HSA registration DE0500664

Bard Atlas Gold PTA Dilatation Catheter

Singapore flagSingapore·CLASS D·Bard Peripheral Vascular, Inc·Registered September 18, 2017
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0500664
Registration Date
September 18, 2017
Change Notification Approval Date
May 02, 2025
Retention Due Date
September 17, 2025
Product description
Atlas Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
Product Owner
Name
Bard Peripheral Vascular, Inc
Short Name
Bard
Address
1625 West 3rd Street, Tempe, AZ 85281, UNITED STATES
Registrant
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
Model Name(s)
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Model Identifier(s)
ATG120122 ATG120124 ATG120126 ATG120142 ATG120144 ATG120146 ATG120162 ATG120164 ATG120166 ATG120182 ATG120184 ATG120186 ATG120202 ATG120204 ATG120222 ATG120224 ATG120242 ATG120244 ATG120262 ATG120264 ATG80122 ATG80124 ATG80126 ATG80142 ATG80144 ATG80146 ATG80162 ATG80164 ATG80166 ATG80182 ATG80184 ATG80186 ATG80202 ATG80204 ATG80222 ATG80224 ATG80242 ATG80244 ATG80262 ATG80264
About this record

Access comprehensive regulatory information for Bard Atlas Gold PTA Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0500664 and owned by Bard Peripheral Vascular, Inc. The device was registered on September 18, 2017.

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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