đź“‹ FDA Reference
Seeker Crossing Support Catheter
Summary: The Seeker Crossing Support Catheter is a medical device used to facilitate the crossing of lesions in venous interventions. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K103367 ↗
Decision Date ?
December 8, 2010
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Seeker Crossing Support Catheter was cleared through the FDA 510(k) pathway on December 8, 2010. It is manufactured by Bard Peripheral Vascular and classified as a Class 2 device under product code DQY.
What It Is
The Seeker Crossing Support Catheter is designed to assist in navigating and crossing complex venous lesions. It provides support and stability for guidewires during endovascular procedures. The catheter's design allows for enhanced maneuverability and control, which is essential in challenging vascular anatomy.
FDA-Cleared Indications
- Used to facilitate the crossing of vascular lesions during percutaneous endovascular procedures.
- Used to provide support and stability for guidewires when navigating lesions that are difficult to cross.
Clinical Applications
- Crossing difficult venous obstructions during endovascular treatment.
- Providing guidewire support during venous stent placement.
- Supporting catheter and guidewire navigation through challenging venous anatomy.
- Use during percutaneous treatment of venous lesions by appropriately trained clinicians.
Practical Considerations
- Available sizes and working characteristics should be matched to the target vessel, lesion, and guidewire system.
- Confirm guidewire and accessory compatibility before use; follow the current device instructions for use.
- The catheter is intended for use with fluoroscopic or other appropriate imaging guidance by trained endovascular clinicians.
- MRI safety depends on the specific device configuration and labeling; review the current manufacturer instructions before an MRI examination.
- Contraindications, warnings, and precautions should be reviewed in the current labeling, including issues related to vascular access, bleeding risk, infection, and inability to safely cross the lesion.
Procedures that use this device
Frequently Asked Questions
What is the Seeker Crossing Support Catheter used for?
It is used to facilitate the crossing of lesions in venous interventions, aiding in the placement of stents or other devices.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in crossing vascular lesions, particularly in venous obstructions requiring intervention.
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.