📋 FDA Reference
Cordis Hi-Flex Pervenous Active Fixation Unipolar
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 ?
510(k)
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.
FDA-Cleared Indications
- Placement of an inferior vena cava filter to help prevent pulmonary embolism in patients at risk for venous thromboembolism.
- Use in patients who cannot receive anticoagulation therapy because of a contraindication.
- Use in patients who develop recurrent embolism despite adequate anticoagulation.
Clinical Applications
- Catheter-based placement of an IVC filter through the venous system.
- Prevention of pulmonary embolism in selected patients with a risk of venous thromboembolism.
- IVC filter placement when anticoagulation is contraindicated.
- IVC filter placement when pulmonary embolic events recur despite appropriate anticoagulation.
Practical Considerations
- The device is intended for use by clinicians trained in venous catheterization and IVC filter placement.
- The active fixation mechanism requires careful handling and accurate positioning before deployment or fixation.
- Available sizes and sheath or guidewire compatibility should be confirmed in the product labeling before the procedure.
- MRI safety and conditional-use information should be verified from the current manufacturer labeling; this historical FDA record alone does not establish MRI compatibility.
- The risks and benefits of IVC filter placement should be assessed against anticoagulation and other treatment options, including the risk of filter-related thrombosis, migration, perforation, or difficulty with retrieval when applicable.
Procedures that use this device
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.