Cvi 8 5 French Percutaneous Sheath Introducer Sys

FDA-Cleared Indications

• To provide vascular access for the introduction of catheters and other medical devices into the vascular system.
• For use during procedures requiring percutaneous vascular access, including diagnostic angiographic studies and catheter-based interventions.

Clinical Applications

• Percutaneous vascular access for angiography and other diagnostic imaging procedures.
• Access for catheter-based embolization procedures.
• Introduction of catheters and interventional devices during vascular procedures.

Reported off-label uses

• Use as access for other catheter-based interventions when the sheath size, anatomy, and device compatibility are appropriate; this should be determined by the treating clinician and applicable 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

• The system is described as an 8.5 French sheath introducer; clinicians should confirm the actual outer diameter, inner diameter, usable length, and included components in the current product labeling.
• The sheath must be compatible with the intended catheter or device, including its shaft diameter and required working length.
• Vessel size, access-site anatomy, anticoagulation status, and bleeding risk should be assessed before placement.
• Insertion should be performed using appropriate sterile technique and imaging guidance when indicated to reduce bleeding, vessel injury, infection, and malposition.
• MRI safety cannot be determined from the FDA clearance record provided. Confirm the current manufacturer's MRI labeling before scanning a patient with any component in place; the sheath is generally intended for temporary procedural use and should be removed according to its instructions for use.