📋 FDA Reference

Multicath - Code S 8 1207 Oo 8 1208 00 8 1205 20

Vygon Corporation

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Summary: The Multicath by Vygon is a venous catheter used for vascular access. It's primarily utilized in hospitals by healthcare professionals for patients requiring intravenous therapy.

FDA Clearance Information

Pathway ? 510(k)
Number ? K870067 ↗
Decision Date ? April 28, 1987
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

The Multicath was cleared through the FDA 510(k) pathway on April 28, 1987. Manufactured by Vygon, it is classified as a Class 2 medical device under product code DQY.

What It Is

The Multicath is a multi-lumen venous catheter designed for vascular access. It facilitates the simultaneous administration of medications, fluids, and the monitoring of central venous pressure. The device is typically inserted into a large vein, such as the subclavian or jugular vein, and is used in both acute and chronic care settings.

FDA-Cleared Indications

  • Percutaneous catheterization of a vein to establish vascular access.
  • Administration of intravenous fluids and medications when venous access is required.
  • Use of venous access for patients who require intravenous therapy in hospital care.

Clinical Applications

  • Establishing percutaneous venous access in a hospital setting.
  • Administering intravenous medications and fluids.
  • Providing venous access during surgical or intensive-care treatment.
  • Supporting intravenous therapy when repeated peripheral venous access is inadequate.

Reported off-label uses

  • Central venous pressure monitoring when the specific catheter configuration and labeling support that use.
  • Administration of parenteral nutrition through a suitably positioned central venous catheter.
  • Use as venous access during endovascular procedures, when selected and handled according to institutional practice.

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 record covers multiple Multicath code configurations; catheter size, lumen configuration, length, and exact labeling should be confirmed for the specific catalog number.
  • Insertion should be performed by trained healthcare professionals using sterile technique and appropriate imaging or procedural guidance.
  • The catheter must be connected to compatible infusion and monitoring equipment, with attention to lumen size, flow requirements, and medication compatibility.
  • MRI safety cannot be determined from this FDA record alone; review the current product labeling for the exact catheter and any components before MRI.
  • Potential complications include bleeding, infection, thrombosis, catheter malposition, vessel injury, air embolism, and procedure-related complications.

Procedures that use this device

Frequently Asked Questions

What is Multicath used for?

The Multicath 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 surgery commonly use the Multicath.

What are the FDA-cleared indications?

The Multicath is indicated for central venous access in patients requiring intravenous therapy, fluid administration, 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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