📋 FDA Reference
Permanthane 866 Bipolar Coaxial
Pacesetter Systems
Summary: The Permanthane 866 Bipolar Coaxial is a medical device used primarily in interventional cardiology for procedures involving IVC filters. It is utilized by cardiologists and interventional radiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K832987 ↗
Decision Date ?
October 20, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Permanthane 866 Bipolar Coaxial was cleared through the FDA 510(k) pathway on October 20, 1983, by Pacesetter Systems. It is classified as a Class III device under product code DTB.
What It Is
The Permanthane 866 Bipolar Coaxial is a specialized medical device designed for use in procedures involving inferior vena cava (IVC) filters. It features a bipolar coaxial design, which aids in precise placement and stability of the filter within the vena cava. This device is crucial in preventing pulmonary embolism by capturing blood clots before they reach the lungs.
FDA-Cleared Indications
- Use during placement of an inferior vena cava filter to help prevent pulmonary embolism.
- Use in patients for whom an IVC filter is indicated because of venous thromboembolism risk or limitations on anticoagulant treatment.
Clinical Applications
- Catheter-based placement of an IVC filter in the inferior vena cava.
- Filter placement for patients at risk of pulmonary embolism from deep vein thrombosis or other venous thromboembolism.
- Use in a hospital catheterization laboratory or interventional radiology suite during image-guided IVC-filter procedures.
Practical Considerations
- Confirm that the device is compatible with the specific IVC-filter model and delivery system before the procedure.
- Select equipment appropriate for the patient's venous anatomy and the intended filter size; the available sizes and specifications should be verified in the original labeling.
- Deployment requires image guidance and familiarity with coaxial catheter technique to position the filter accurately.
- The record provided does not establish MRI safety. MRI conditions should be confirmed from the original manufacturer labeling or current institutional device guidance.
- Assess contraindications to IVC-filter placement, including inability to safely access the venous system, unsuitable caval anatomy, active infection at the access site, or other patient-specific risks.
Procedures that use this device
Frequently Asked Questions
What is Permanthane 866 Bipolar Coaxial used for?
It is used for the placement of inferior vena cava (IVC) filters to prevent pulmonary embolism.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring IVC filter placement to prevent pulmonary embolism, especially those with venous thromboembolism.
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.