6f Taiga Guiding Catheter

FDA-Cleared Indications

• Used to facilitate the placement of interventional and therapeutic devices within the peripheral vascular system.
• Intended for percutaneous vascular procedures requiring catheter guidance and device delivery.
• The FDA clearance is associated with product code DQY, Catheter, Percutaneous, under 21 CFR 870.1250.

Clinical Applications

• Providing a conduit for guidewires, balloons, stents, and other compatible therapeutic devices during percutaneous vascular procedures.
• Supporting catheter-based treatment of peripheral vascular narrowing or obstruction when device delivery is required.
• Accessing and navigating vessels under fluoroscopic or other appropriate imaging guidance.
• Facilitating placement of therapeutic devices in selected peripheral vascular interventions.

Reported off-label uses

• Use in venous interventions such as iliac or central venous stent delivery may occur in clinical practice, but the specific use should be confirmed against the current device labeling and institutional policy.
• Use as an access or delivery catheter in other vascular territories may be considered by clinicians when compatible with the catheter's specifications, although this may be outside the cleared indication.

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 6F size refers to an approximately 2 mm outer diameter; the required sheath, guidewire, and accessory devices must be compatible with the catheter's specifications.
• The catheter is placed percutaneously through vascular access and advanced under imaging guidance, commonly with local anesthesia and optional moderate sedation.
• Do not use the catheter if it is damaged, kinked, or incompatible with the intended guidewire or therapeutic device. Follow the current instructions for use for flushing, preparation, and maximum pressure limits.
• MRI safety depends on the exact catheter model and whether it remains in the patient; consult the current labeling before MRI examination.
• Potential complications are related to catheterization and the underlying procedure and may include bleeding, hematoma, vessel injury, thrombosis, embolization, infection, contrast reaction, or arrhythmia depending on the access site and treatment.