Kdl Micro Catheter

FDA-Cleared Indications

• Percutaneous catheter access to the vascular system.
• Delivery of therapeutic agents or compatible devices during vascular procedures.
• Use in selected vascular territories where a small, flexible catheter is needed for navigation and delivery.

Clinical Applications

• Catheter-directed delivery of therapeutic agents during vascular interventions.
• Delivery of compatible endovascular devices through a percutaneous vascular approach.
• Navigation through small or tortuous vessels during image-guided vascular procedures.

Reported off-label uses

• Selective embolization procedures when the catheter configuration and labeled compatibility requirements are appropriate.
• Targeted infusion procedures in vascular territories not specifically described in the device labeling.

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

• Available catheter dimensions, working length, distal configuration, and compatibility should be matched to the target vessel, guidewire, and delivery device.
• The catheter is generally advanced over a compatible guidewire under fluoroscopic or other appropriate imaging guidance.
• Use requires sterile technique and familiarity with vascular access, catheter manipulation, and management of complications such as dissection, perforation, thrombosis, or bleeding.
• MRI safety depends on the specific device labeling and its components; verify the manufacturer’s current MRI information before scanning.
• Contraindications, warnings, and compatibility limits in the current instructions for use should be reviewed before each procedure.