Kyphoplasty systems

Balloon Catheter Syringe Pump

by Shanghai Kinetic Medical Co., Ltd.

A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

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Balloon Catheter Syringe Pump models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
FG4011Length 30 cm; Pressure 440 Pound per Square Inch Not statedAvailable
FG4013Length 60 cm Not statedAvailable

FDA clearances

  • 510(k) K113742 September 2012

Procedures that use kyphoplasty systems

Frequently asked questions

What is Balloon Catheter Syringe Pump used for?

A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Who makes Balloon Catheter Syringe Pump?

Balloon Catheter Syringe Pump is made by Shanghai Kinetic Medical Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does Balloon Catheter Syringe Pump come in?

Sizes listed for Balloon Catheter Syringe Pump: Length: 30–60 cm; Pressure: 440 Pound per Square Inch. Confirm availability with the manufacturer's instructions for use.

Is Balloon Catheter Syringe Pump MRI safe?

The FDA device database entry for Balloon Catheter Syringe Pump does not state its MRI safety status. Check the labeling before MRI.

Is Balloon Catheter Syringe Pump FDA cleared?

Balloon Catheter Syringe Pump is covered by FDA submission K113742.

How do I contact a Shanghai Kinetic Medical Co., Ltd. sales representative?

Shanghai Kinetic Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Shanghai Kinetic Medical Co., Ltd. company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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