Guidewires
HYBRID Guidewire
by Balt USA LLC
A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
HYBRID Guidewire 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 |
|---|---|---|---|
| HYBRID007D | — | Not stated | Available |
| HYBRID007D.120 | — | Not stated | Available |
| HYBRID007J | — | Not stated | Available |
| HYBRID008D | — | Not stated | Available |
| HYBRID008J | — | Not stated | Available |
| HYBRID014D | — | Not stated | Available |
| HYBRID10D300 | — | Not stated | Available |
| HYBRID12D300 | — | Not stated | Available |
| HYBRID1214D | — | Not stated | Available |
| HYBRID1214DA | — | Not stated | Available |
FDA clearances
- 510(k) K182337 October 2018
Procedures that use guidewires
Frequently asked questions
What is HYBRID Guidewire used for?
A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Who makes HYBRID Guidewire?
HYBRID Guidewire is made by Balt USA LLC. It is listed under guidewires in our device library.
What sizes does HYBRID Guidewire come in?
The FDA device database does not list sizes for HYBRID Guidewire. Check the instructions for use or ask a Balt USA LLC representative.
Is HYBRID Guidewire MRI safe?
The FDA device database entry for HYBRID Guidewire does not state its MRI safety status. Check the labeling before MRI.
Is HYBRID Guidewire FDA cleared?
HYBRID Guidewire is covered by FDA submission K182337.
How do I contact a Balt USA LLC sales representative?
Balt USA LLC has not listed representatives on LA Vascular yet. Visit the Balt USA LLC 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.