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MAQUET Fidelity Intra-aortic Balloon Catheter - HSA Registration DE0008490

Access comprehensive regulatory information for MAQUET Fidelity 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 DE0008490 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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CLASS D
DE0008490
MAQUET Fidelity Intra-aortic Balloon Catheter
HSA Registration Number: DE0008490
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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.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0008490
Registration Date
February 20, 2012
Retention Due Date
February 19, 2026
Product Owner
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 .025โ€(+0,/-.001โ€) x 145cm PTFE Coated (Type L) Stainless Steel J3FC-SS 175-025, Sterile Pouched Guide Wire .025โ€(+0,/-.001โ€) x 175cm PTFE Coated (Type L) Stainless Steel J3FC-SS 260-025, Sterile Pouched Guide Wire .025โ€(+0,/-.001โ€) 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 0334-00-1403-01 R5 8 FRENCH+A91 6" LENGTH (15cm) Fidelity 8 Fr. 25cc Fidelity 8 Fr. 25cc Fidelity 8 Fr. 34cc Fidelity 8 Fr. 34cc Fidelity 8 Fr. 40cc Fidelity 8 Fr. 40cc Arrow Pump Adapter Insertion Kit with 6" (15cm) Introducer for use with Fidelity 8 Fr. 25cc IAB Insertion Kit with 6" (15cm) Introducer for use with Fidelity 8 Fr. 34cc & 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 0684-00-0403-01 0684-00-0429-01 0684-00-0429-02 0684-00-0430-01 0684-00-0430-02 0684-00-0431-01 0684-00-0431-02 0684-00-0510-01 0884-00-0019-09 0884-00-0019-10