Kyphoplasty systems
B-Two Inflatable bone expander system syringe
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 B-Two Inflatable bone expander system syringe
We do not have contact details for Imedicom Co., Ltd. yet. Send a request and we will route it to the right person for your country.
B-Two Inflatable bone expander system 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 |
|---|---|---|---|
| US103002 | — | Not stated | Available |
FDA clearances
- 510(k) K153296 July 2016
Procedures that use kyphoplasty systems
Frequently asked questions
What is B-Two Inflatable bone expander system 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 B-Two Inflatable bone expander system syringe?
B-Two Inflatable bone expander system syringe is made by Imedicom Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does B-Two Inflatable bone expander system syringe come in?
The FDA device database does not list sizes for B-Two Inflatable bone expander system syringe. Check the instructions for use or ask a Imedicom Co., Ltd. representative.
Is B-Two Inflatable bone expander system syringe MRI safe?
The FDA device database entry for B-Two Inflatable bone expander system syringe does not state its MRI safety status. Check the labeling before MRI.
Is B-Two Inflatable bone expander system syringe FDA cleared?
B-Two Inflatable bone expander system syringe is covered by FDA submission K153296.
How do I contact a Imedicom Co., Ltd. sales representative?
Imedicom Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Imedicom 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.