Guidewires
INT,Denali Guide Wire
by Shanghai Kindly Medical Instruments Co., Ltd.
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.
INT,Denali Guide Wire 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 |
|---|---|---|---|
| HG144SF | — | Not stated | Available |
| HG148SF | Length 300 cm | Not stated | Available |
| HG184SF | Length 180 cm | Not stated | Available |
| HG188SF | Length 300 cm | Not stated | Available |
FDA clearances
- 510(k) K180177 September 2018
Procedures that use guidewires
Frequently asked questions
What is INT,Denali Guide Wire 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 INT,Denali Guide Wire?
INT,Denali Guide Wire is made by Shanghai Kindly Medical Instruments Co., Ltd.. It is listed under guidewires in our device library.
What sizes does INT,Denali Guide Wire come in?
Sizes listed for INT,Denali Guide Wire: Length: 180–300 cm. Confirm availability with the manufacturer's instructions for use.
Is INT,Denali Guide Wire MRI safe?
The FDA device database entry for INT,Denali Guide Wire does not state its MRI safety status. Check the labeling before MRI.
Is INT,Denali Guide Wire FDA cleared?
INT,Denali Guide Wire is covered by FDA submission K180177.
How do I contact a Shanghai Kindly Medical Instruments Co., Ltd. sales representative?
Shanghai Kindly Medical Instruments Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Shanghai Kindly Medical Instruments 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.