📋 FDA Reference

Mediziv Central Vein Catheter

Mediziv Medical Devices

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Summary: The Mediziv Central Vein Catheter is a medical device used for central venous access, primarily in hospital settings. It is utilized by healthcare professionals for administering medications, fluids, and for monitoring central venous pressure.

FDA Clearance Information

Pathway ? 510(k)
Number ? K884491 ↗
Decision Date ? June 5, 1989
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

The Mediziv Central Vein Catheter was cleared through the FDA 510(k) pathway on June 5, 1989, by Mediziv Medical Devices. It is classified as a Class 2 device under product code DQY.

What It Is

The Mediziv Central Vein Catheter is a flexible tube inserted into a large vein, typically in the neck, chest, or groin, to provide central venous access. It is designed to facilitate the administration of medications, fluids, and parenteral nutrition, as well as to allow for blood sampling and hemodynamic monitoring. The catheter's design ensures durability and ease of insertion, making it a reliable choice for clinicians.

FDA-Cleared Indications

  • Provide central venous access for intravenous administration of medications and fluids.
  • Provide access for patients requiring prolonged or repeated intravenous therapy.
  • Allow blood sampling and central venous pressure or hemodynamic monitoring when clinically indicated.

Clinical Applications

  • Central venous access for intravenous medications and fluids
  • Administration of parenteral nutrition when central access is required
  • Blood sampling through a central venous catheter
  • Central venous pressure or hemodynamic monitoring
  • Placement through a large vein in the neck, chest, or groin

Reported off-label uses

  • Use as access during selected endovascular procedures, such as venous interventions, when the catheter's configuration and labeling are appropriate

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 intended access vein.
  • Placement requires sterile or aseptic technique and appropriate clinician training; ultrasound guidance is commonly used to improve venous access and reduce complications.
  • Confirm compatibility with infusion solutions, pressure-injection requirements, guidewires, dilators, and other components before use.
  • MRI safety depends on the specific catheter materials and configuration; review the current product labeling before an MRI examination.
  • Potential complications include infection, bleeding, thrombosis, catheter malposition, vessel injury, air embolism, and pneumothorax depending on the access site. Do not use when central venous catheterization is contraindicated for the individual patient.

Procedures that use this device

Frequently Asked Questions

What is the Mediziv Central Vein Catheter used for?

It is used for central venous access to administer medications, fluids, and for monitoring central venous pressure.

What specialties typically use this device?

Specialties such as anesthesiology, critical care, and oncology commonly use this device.

What are the FDA-cleared indications?

The catheter is indicated for providing central venous access for patients needing long-term intravenous therapy, frequent blood sampling, or hemodynamic monitoring.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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