Curity Central Venous Catheter

FDA-Cleared Indications

• Central venous access for administration of medications and fluids.
• Central venous access when peripheral venous access is inadequate or unsuitable.
• Central venous pressure monitoring when clinically indicated.

Clinical Applications

• Administration of intravenous medications through a central vein.
• Delivery of intravenous fluids requiring central venous access.
• Central venous access during hospital-based medical or surgical care.
• Central venous pressure monitoring when included in the treatment plan.

Reported off-label uses

• Administration of total parenteral nutrition.
• Administration of chemotherapy.
• Prolonged intravenous therapy for conditions such as severe infection.

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 sizes and configurations should be selected according to the patient’s anatomy, treatment requirements, and the specific product labeling.
• Placement requires aseptic technique and trained clinicians to reduce risks such as infection, bleeding, thrombosis, and malposition.
• The catheter is compatible with standard percutaneous central venous insertion techniques; ultrasound and radiographic confirmation may be used according to institutional practice.
• MRI safety cannot be determined from the FDA classification or product code alone. Confirm the exact catheter model and labeling before an MRI examination.
• Contraindications and precautions include local infection at the access site, uncorrected bleeding risk, and inability to safely access or maintain the intended central vein.