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Minnie Support Catheter
Summary: The Minnie Support Catheter is a medical device used primarily in vascular procedures to facilitate the placement of stents. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082337 ↗
Decision Date ?
January 15, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Minnie Support Catheter was cleared through the FDA 510(k) pathway on January 15, 2009. It is manufactured by Vascular Solutions and classified as a Class 2 device under product code DQY.
What It Is
The Minnie Support Catheter is a specialized catheter designed to support the delivery and placement of venous stents. It provides a stable platform for advancing stents through the vascular system, particularly in challenging anatomical regions. The catheter's design allows for flexibility and precision, making it a valuable tool in endovascular procedures.
FDA-Cleared Indications
- Percutaneous intravascular use as a catheter to provide support during vascular procedures, consistent with FDA product code DQY and the device's 510(k) clearance.
- Use by trained clinicians to facilitate the introduction or advancement of compatible interventional devices through the vasculature.
Clinical Applications
- Providing support during percutaneous vascular interventions.
- Facilitating advancement of compatible catheters or interventional devices through tortuous or difficult vascular anatomy.
- Supporting endovascular access during procedures involving peripheral or central blood vessels.
Reported off-label uses
- Use as additional support during venous stent delivery or placement may occur in clinical practice, but this specific application should be confirmed against the current device labeling and institutional protocols.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Confirm the catheter diameter, length, guidewire requirements and compatibility with the intended access system and interventional device before use.
- Use fluoroscopic or other appropriate imaging guidance and follow the current manufacturer instructions for preparation, advancement and withdrawal.
- Catheter handling requires attention to vessel size, tortuosity, resistance and the risk of vessel injury, dissection, perforation, thrombosis or embolization.
- MRI safety depends on the exact catheter model and labeling; do not assume that the device is MR safe or MR conditional without reviewing the current instructions for use.
- Contraindications, warnings and maximum pressure or torque limits should be taken from the current manufacturer labeling rather than inferred from the FDA product code.
Procedures that use this device
Frequently Asked Questions
What is the Minnie Support Catheter used for?
The Minnie Support Catheter is used to facilitate the placement of venous stents in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring venous stent placement, such as those with venous obstructions or stenosis.
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.