Singapore HSA registration DE0008489
Datascope Linear Intra-aortic Balloon Catheter
Singapore·CLASS D·Datascope Corp·Registered February 20, 2012Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0008489
- Registration Date
- February 20, 2012
- Change Notification Approval Date
- October 23, 2024
- Retention Due Date
- February 19, 2026
Product description
Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Product Owner
- Name
- Datascope Corp
- Short Name
- Datascope
- Address
- 15 Law Drive, Fairfield, NJ 07004, UNITED STATES
Registrant
- Address
- 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
- Address
- 20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model information
- Model Name(s)
- Adult Safety Chamber IAB CATHETER EXTENDER for DATASCOPE IABP ONLY J3FC-SS 145-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 145cm PTFE Coated (Type L) Stainless Steel J3FC-SS 175-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 175cm PTFE Coated (Type L) Stainless Steel J3FC-SS 260-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 260cm PTFE Coated (Type L) Stainless Steel DATASCOPE CATHETER EXTENDER For use with Datascope 25cc IAB's ONLY REINFORCED INTRODUCER SET With Hemostasis Valve 0334-00-1403-05 R2 For use with Linear 7.5 Fr. IAB Linear 7.5 Fr. 25cc Linear 7.5 Fr. 25cc Linear 7.5 Fr. 34cc Linear 7.5 Fr. 34cc Linear 7.5 Fr. 40cc Linear 7.5 Fr. 40cc Arrow Pump Adapter Insertion Kit with 6" (15cm) Introducer for use with Linear 7.5 Fr. 25cc IABs Insertion Kit with 6" (15cm) Introducer for use with Linear 7.5 Fr. 34 & 40cc IABs
- Model Identifier(s)
- 0683-00-0187 0684-00-0186 0684-00-0254-09 0684-00-0254-14 0684-00-0254-15 0684-00-0325 0684-00-0403-05 0684-00-0478-01 0684-00-0478-02 0684-00-0479-01 0684-00-0479-02 0684-00-0480-01 0684-00-0480-02 0684-00-0510-01 0884-00-0019-12 0884-00-0019-13
About this record
Access comprehensive regulatory information for Datascope Linear Intra-aortic Balloon 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 DE0008489 and owned by Datascope Corp. The device was registered on February 20, 2012.
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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