📋 FDA Reference
Bantam Catheter 280mm Balloon Lengths
Summary: The Bantam Catheter with 280mm balloon is a medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112335 ↗
Decision Date ?
October 12, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Bantam Catheter 280mm Balloon by Clearstream Technologies was cleared via the FDA 510k pathway on October 12, 2011. It is a Class 2 device under product code DQY.
What It Is
The Bantam Catheter is a specialized catheter featuring a 280mm balloon designed for use in venous stenting procedures. It is used to dilate veins and facilitate the placement of stents to treat venous obstructions. The balloon's length allows for treatment of longer segments of veins, which can be beneficial in complex cases.
FDA-Cleared Indications
- Percutaneous transluminal dilatation of stenotic or obstructed vessels when balloon catheter dilation is clinically indicated.
- Use in interventional procedures involving the treatment of venous narrowing or obstruction, consistent with the device classification and cleared labeling.
Clinical Applications
- Balloon dilation of narrowed venous segments before or during venous stent placement.
- Treatment of long-segment venous stenosis or obstruction when the 280 mm balloon length is appropriate.
- Adjunctive balloon angioplasty during iliac or central venous stenting procedures.
Practical Considerations
- The 280 mm balloon is intended for treatment of relatively long venous segments; the selected diameter and length must match the target vessel and treatment plan.
- Confirm guidewire, sheath, catheter, and stent compatibility before use, and follow the device-specific instructions for preparation, inflation, and rated pressure.
- Use fluoroscopic or other appropriate imaging guidance and avoid overinflation, which can increase the risk of venous dissection, perforation, rupture, or thrombosis.
- MRI safety information is device- and labeling-specific. Review the current manufacturer instructions before MRI; do not assume the catheter is safe while retained in the patient.
- Contraindications, anticoagulation requirements, and access-site precautions should be assessed according to the patient's anatomy, the planned intervention, and the current instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Bantam Catheter 280mm Balloon used for?
It is used for venous stenting procedures to treat venous obstructions and improve blood flow.
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 use in venous stenting procedures to treat narrowed or blocked veins.
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.