Kyphoplasty systems
GUARDIAN-SG Inflatable Bone Expander System
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 GUARDIAN-SG Inflatable Bone Expander System
We do not have contact details for Bm Korea Co., Ltd yet. Send a request and we will route it to the right person for your country.
GUARDIAN-SG Inflatable Bone Expander System 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 |
|---|---|---|---|
| 2BMK(T)15αS | Length 15 mm | Not stated | Available |
| BMK(T)15αS | — | Not stated | Available |
FDA clearances
- 510(k) K143006 January 2015
Procedures that use kyphoplasty systems
Frequently asked questions
What is GUARDIAN-SG Inflatable Bone Expander System 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 GUARDIAN-SG Inflatable Bone Expander System?
GUARDIAN-SG Inflatable Bone Expander System is made by Bm Korea Co., Ltd. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does GUARDIAN-SG Inflatable Bone Expander System come in?
Sizes listed for GUARDIAN-SG Inflatable Bone Expander System: Length: 15 mm. Confirm availability with the manufacturer's instructions for use.
Is GUARDIAN-SG Inflatable Bone Expander System MRI safe?
The FDA device database entry for GUARDIAN-SG Inflatable Bone Expander System does not state its MRI safety status. Check the labeling before MRI.
Is GUARDIAN-SG Inflatable Bone Expander System FDA cleared?
GUARDIAN-SG Inflatable Bone Expander System is covered by FDA submission K143006.
How do I contact a Bm Korea Co., Ltd sales representative?
Bm Korea Co., Ltd has not listed representatives on LA Vascular yet. Visit the Bm Korea 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.