📋 FDA Reference
Vascular Access Port Cath Cat Vp-Xxx Vasport Ser
Gish Biomedical
Summary: The Vascular Access Port Cath Cat VP-XXX Vasport Ser is a medical device used for long-term venous access. It is commonly utilized by oncologists and other specialists for administering chemotherapy or other intravenous treatments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K873035 ↗
Decision Date ?
September 25, 1987
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Vascular Access Port Cath Cat VP-XXX Vasport Ser was cleared through the FDA 510(k) pathway on September 25, 1987. It is manufactured by Gish Biomedical and is classified as a Class 2 device.
What It Is
The Vascular Access Port Cath Cat VP-XXX Vasport Ser is a vascular access port designed for long-term venous access. It consists of a small reservoir implanted under the skin, connected to a catheter that enters a vein. This device allows for repeated access to the venous system for the delivery of medications, fluids, or for blood sampling, minimizing the need for repeated needle sticks.
FDA-Cleared Indications
- Long-term access to the venous system for patients who require repeated intravenous treatment.
- Administration of prescribed medications or fluids through a central venous catheter.
- Repeated withdrawal of blood when ongoing venous access is clinically necessary.
Clinical Applications
- Long-term intravenous access for recurring infusion therapy.
- Administration of intravenous medications, including chemotherapy when indicated by the treating clinician.
- Administration of intravenous fluids or other prescribed infusion therapies.
- Repeated blood sampling through an implanted venous access port.
Reported off-label uses
- Long-term administration of parenteral nutrition when a suitable central venous access device is required.
- Administration of blood products in patients who need durable central venous access.
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 port requires surgical or interventional implantation, usually with the reservoir placed under the skin of the chest and the catheter advanced into a central vein.
- Only compatible non-coring port needles and appropriate infusion or sampling equipment should be used, according to the device instructions and institutional protocol.
- Port access and maintenance require trained personnel, sterile technique, flushing, and monitoring for infection, thrombosis, occlusion, catheter malposition, or mechanical damage.
- The record does not specify MRI labeling or a universal range of port sizes. MRI conditions, catheter configuration, and available sizes should be confirmed in the original manufacturer documentation before use.
- Contraindications and precautions may include active infection at the implantation site, bloodstream infection, unsuitable venous anatomy, or inability to safely undergo the implantation procedure.
Related Literature
The linked study titled 'Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia' explores the use of ascorbic acid in combination with chemotherapy. Although the abstract is not available, the study likely investigates the efficacy and safety of this combination treatment. Limitations include the lack of detailed results and the absence of a publication year, which may affect the study's relevance.
Frequently Asked Questions
What is Vascular Access Port Cath Cat VP-XXX Vasport Ser used for?
It is used for long-term venous access to administer medications, fluids, or for blood sampling.
What specialties typically use this device?
Oncology, hematology, and any specialty requiring long-term intravenous therapy use this device.
What are the FDA-cleared indications?
The device is indicated for providing long-term venous access for patients needing frequent intravenous treatments.
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.