Multicath - Code S 8 1207 Oo 8 1208 00 8 1205 20
FDA Clearance Information
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
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.