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cordis hi-flex pervenous active fixation unipolar
Cordis
Summary: The Cordis Hi-Flex Pervenous Active Fixation Unipolar is a medical device used primarily in the placement of inferior vena cava (IVC) filters. It is utilized by interventional radiologists and vascular surgeons to prevent pulmonary embolism in at-risk patients.
FDA Clearance Information
Pathway
510K
Number
K851064 ↗
Decision Date
August 5, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Hi-Flex Pervenous Active Fixation Unipolar was cleared through the FDA 510(k) pathway on August 5, 1986. It is manufactured by Cordis and classified as a Class III device under the product code DTB.
What It Is
The Cordis Hi-Flex Pervenous Active Fixation Unipolar is a specialized catheter designed for the placement of IVC filters. It features an active fixation mechanism that ensures stable positioning within the venous system. This device is crucial in procedures aimed at preventing blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant for patients who are at high risk for venous thromboembolism and cannot be managed with anticoagulation therapy alone. The device is used in hospital settings, often in the operating room or interventional suite, and is suitable for adult patients with specific indications for IVC filter placement.
Indications for Use
The FDA indications for this device involve the prevention of pulmonary embolism in patients who are at risk of venous thromboembolism. It is particularly indicated for patients who have contraindications to anticoagulation therapy or have experienced recurrent embolism despite adequate anticoagulation.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is compatible with standard guidewires and introducer sheaths used in vascular procedures. Clinicians should be familiar with the active fixation mechanism to ensure proper deployment and positioning.
Frequently Asked Questions
What is the Cordis Hi-Flex Pervenous Active Fixation Unipolar used for?
It is used for the placement of IVC filters to prevent pulmonary embolism in at-risk patients.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for preventing pulmonary embolism in patients who cannot be managed with anticoagulation therapy or have recurrent embolism despite treatment.
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.