Datascope Mega Intra-aortic Balloon Catheter

Singapore - English - HSA (Health Sciences Authority)

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Available from:
GETINGE SOUTH EAST ASIA PTE. LTD.
Class:
Class D medical device
Manufactured by:
Datascope Corp
Therapeutic area:
Cardiovascular
Therapeutic indications:
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 summary:
Device System Info:[Sterile Medical Device], ETO.; Models: Mega 50 8 Fr. 50cc - 0684-00-0498-01, Mega 50 8 Fr. 50cc - 0684-00-0498-02, Insertion Kit with 6” (15cm) Introducer for use with Mega 8 Fr. 50cc IAB - 0884-00-0019-17, J3FC-SS 145-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 145cm PTFE Coated (Type L) Stainless Steel - 0684-00-0254-09, J3FC-SS 175-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 175cm PTFE Coated (Type L) Stainless Steel - 0684-00-0254-14, J3FC-SS 260-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 260cm PTFE Coated (Type L) Stainless Steel - 0684-00-0254-15, Adult Safety Chamber - 0683-00-0187, Catheter Extender For MEGA 8Fr. 50cc IAB ONLY - 0684-00-0526, Arrow Pump Adapter - 0684-00-0510-01, Arrow Pump Adapter For use with MEGA 8Fr. 50cc IAB Only - 0684-00-0510-02, MEGA 7.5 Fr. 30cc IAB Catheter with STATLOCK - 0684-00-0294-01, MEGA 7.5Fr. 30cc IAB Catheter with STATLOCK - 0684-00-0294-02, MEGA 7.5Fr. 40cc IAB Catheter with STATLOCK - 0684-00-0295-01, MEGA 7.5Fr. 40cc IAB Catheter with STATLOCK - 0684-00-0295-02, MEGA 8Fr. 50cc IAB Catheter with STATLOCK - 0684-00-0296-01, MEGA 8Fr. 50cc IAB Catheter with STATLOCK - 0684-00-0296-02, Insertion Kit with 7.5Fr 6" (15cm) Introducer for use with MEGA 7.5Fr 30 &40 cc IABs - 0884-00-0019-21, REINFORCED INTRODUCER SET With Hemostasis Valve For use with MAQUET 7.5Fr. IAB - 0684-00-0403-05, REINFORCED INTRODUCER SET With Hemostasis Valve For use with MAQUET 8Fr. IAB - 0684-00-0403-10, Catheter Extender for MEGA 7.5Fr. 30 & 40cc IAB's ONLY - 0684-00-0275
Authorization number:
DE0008492
Authorization date:
2012-02-20

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