Kyphoplasty systems
KYPHON Inflation Syringe
by Medtronic Sofamor Danek, Inc.
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.
Where to buy KYPHON Inflation Syringe
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KYPHON Inflation Syringe models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| A08E | — | Not stated | Available |
FDA clearances
- 510(k) K103231 January 2011
Procedures that use kyphoplasty systems
Frequently asked questions
What is KYPHON Inflation Syringe 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 KYPHON Inflation Syringe?
KYPHON Inflation Syringe is made by Medtronic Sofamor Danek, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does KYPHON Inflation Syringe come in?
The FDA device database does not list sizes for KYPHON Inflation Syringe. Check the instructions for use or ask a Medtronic Sofamor Danek, Inc. representative.
Is KYPHON Inflation Syringe MRI safe?
The FDA device database entry for KYPHON Inflation Syringe does not state its MRI safety status. Check the labeling before MRI.
Is KYPHON Inflation Syringe FDA cleared?
KYPHON Inflation Syringe is covered by FDA submission K103231.
How do I contact a Medtronic Sofamor Danek, Inc. sales representative?
Medtronic Sofamor Danek, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic Sofamor Danek, Inc. 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.