📋 FDA Reference

Kerberos Occluding Guide Catheter and Accessories

Kerberos Proximal Solutions

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Summary: The Kerberos Occluding Guide Catheter is a medical device used in vascular procedures to assist in the placement of venous stents. It is primarily used by interventional radiologists and cardiologists.

FDA Clearance Information

Pathway ? 510(k)
Number ? K041151 ↗
Decision Date ? July 22, 2004
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

The Kerberos Occluding Guide Catheter was cleared through the FDA 510(k) pathway on July 22, 2004. It is manufactured by Kerberos Proximal Solutions and is classified as a Class II device.

What It Is

The Kerberos Occluding Guide Catheter is designed to facilitate the delivery and placement of venous stents. It functions by providing a stable and occlusive pathway for the stent to be accurately positioned within the vascular system. The device is typically used in conjunction with other interventional tools to ensure precise stent deployment.

FDA-Cleared Indications

  • Used in percutaneous vascular procedures to provide catheter guidance and access.
  • Used to assist with the placement and positioning of venous stents.
  • Intended for use with compatible interventional devices during endovascular treatment of venous obstruction.

Clinical Applications

  • Guiding delivery systems during iliac or central venous stent placement.
  • Providing temporary proximal occlusion or flow control during a venous stenting procedure.
  • Supporting endovascular treatment of chronic venous obstruction when venous stenting is indicated.
  • Helping maintain a stable pathway for accurate positioning of a venous stent.

Practical Considerations

  • The catheter is available in different sizes; the appropriate size depends on the target vessel, access route and other devices used.
  • Use requires fluoroscopic or other appropriate imaging guidance and compatibility with the selected guidewire, sheath and stent-delivery system.
  • Careful advancement and manipulation are required to reduce the risk of vessel injury, dissection, perforation, thrombosis or embolization.
  • The record provided does not establish MRI safety; consult the current manufacturer labeling before MRI exposure.
  • Contraindications, access-site requirements and anticoagulation decisions should follow the current instructions for use and the treating physician's assessment.

Procedures that use this device

Frequently Asked Questions

What is the Kerberos Occluding Guide Catheter used for?

It is used to assist in the placement of venous stents during vascular procedures.

What specialties typically use this device?

Interventional radiologists and cardiologists commonly use this device.

What are the FDA-cleared indications?

It is indicated for use in procedures involving the placement of venous stents for conditions like venous obstructions.

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.

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