Multipro Catheter
Shiley
FDA Clearance Information
The Multipro Catheter received FDA clearance via the 510(k) pathway on August 10, 1984. Manufactured by Shiley, it is classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Percutaneous catheter use for access to or treatment of the vascular system, consistent with FDA product code DQY.
- Use by trained clinicians in catheter-based vascular procedures under appropriate imaging guidance.
Clinical Applications
- Percutaneous vascular access during endovascular procedures.
- Catheter navigation through selected blood vessels for diagnostic or therapeutic interventions.
- Use in hospital catheterization laboratories by interventional radiologists or vascular surgeons.
Reported off-label uses
- Use as an access or delivery catheter during venous stenting procedures, when compatible with the selected stent system.
- Use during endovascular treatment of venous stenosis or occlusion.
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
- The available FDA record does not specify catheter dimensions, working length, tip configuration, or maximum compatible guidewire or device size; clinicians should verify the original labeling before use.
- Use fluoroscopic or other appropriate imaging guidance and standard sterile vascular-access technique.
- Compatibility with a particular venous stent, guidewire, sheath, contrast agent, or other device must be confirmed from the device labeling and institutional protocol.
- MRI safety cannot be determined from the available record. Do not assume the catheter is MR Safe or MR Conditional without manufacturer documentation.
- Potential complications are those associated with percutaneous vascular catheterization, including bleeding, infection, vessel injury, thrombosis, embolization, contrast reaction, and arrhythmia when applicable.
Procedures that use this device
Frequently Asked Questions
What is the Multipro Catheter used for?
The Multipro Catheter is used for delivering stents in venous stenting procedures to treat venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Multipro Catheter.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring venous stenting to treat narrowed or blocked veins.