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medi-tech selective torque catheter
Medi-Tech
Summary: The Medi-Tech Selective Torque Catheter is a Class 2 medical device used primarily in vascular procedures. It is designed for clinicians specializing in endovascular interventions, particularly in scenarios requiring precise catheter manipulation.
FDA Clearance Information
Pathway
510K
Number
K864118 ↗
Decision Date
April 9, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medi-Tech Selective Torque Catheter was cleared through the FDA 510k pathway on April 9, 1987. It is manufactured by Medi-Tech and is classified as a Class 2 device under product code DQY.
What It Is
The Medi-Tech Selective Torque Catheter is a specialized catheter used in endovascular procedures to navigate through the vascular system. It allows for precise control and manipulation, making it essential for accessing difficult-to-reach areas within the vasculature. This device is particularly useful in procedures where standard catheterization techniques are insufficient.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery, particularly for procedures involving the placement of stents or other vascular interventions. It is often employed in cases where traditional access routes are not feasible, such as in patients with complex vascular anatomy or prior surgical alterations. The device is suitable for use in hospital settings, especially in catheterization labs.
Indications for Use
The FDA indications suggest this device is intended for use in vascular procedures requiring precise catheter navigation. It is suitable for patients needing endovascular interventions, such as those with stenotic or occluded vessels.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with other endovascular devices and ensure appropriate sizing for the patient's vascular anatomy. Familiarity with the device's torque capabilities is essential for effective use, particularly in complex cases.
Related Literature
The linked study reports on a case of transaxillary carotid stenting, highlighting the use of alternative access techniques when the transfemoral approach is not viable. The study demonstrates the successful application of the Medi-Tech Selective Torque Catheter in a patient with an axillary bifemoral bypass graft. While the findings are promising, the study is limited by its single-case nature, necessitating further research to generalize the results.
Frequently Asked Questions
What is the Medi-Tech Selective Torque Catheter used for?
It is used for precise navigation and manipulation in vascular procedures, particularly in challenging anatomical scenarios.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
It is indicated for use in vascular procedures requiring precise catheter manipulation, particularly in patients with complex vascular anatomy.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.