Vascular Access Port Cath Cat Vp-Xxxx Vasport Ser
Gish Biomedical
FDA Clearance Information
The vascular access port cath cat vp-xxxx by Gish Biomedical was cleared via the FDA 510k pathway on May 8, 1986. It is classified as a Class 2 device under the product code DQY.
What It Is
FDA-Cleared Indications
- Long-term access to the venous system for administration of prescribed intravenous therapy.
- Repeated venous access when an implanted port may reduce the need for peripheral needle sticks.
- Administration of medications, fluids, or blood products through a central venous catheter, as specified by the device labeling and clinical treatment plan.
Clinical Applications
- Implanted venous access for patients receiving repeated intravenous treatment.
- Central venous administration of prescribed medications, including chemotherapy when clinically indicated.
- Administration of intravenous fluids or blood products when central venous access is required.
- Blood withdrawal or sampling through the port when permitted by the device instructions and institutional policy.
Practical Considerations
- The port is implanted beneath the skin and connected to a catheter positioned in a central vein; placement is usually performed with sterile technique and imaging guidance when appropriate.
- Ports are accessed with a noncoring needle, and strict aseptic technique is required to reduce infection risk.
- Available sizes and catheter configurations may vary by model; clinicians should confirm compatibility with the intended needle, tubing, infusion system, and medication.
- MRI safety depends on the specific port and catheter components. The exact model should be checked in the manufacturer’s labeling or device records before MRI.
- Potential complications include infection, catheter or port occlusion, thrombosis, bleeding, malposition, catheter damage, and extravasation. The device should not be used when there is a contraindication to central venous access or an active infection at the proposed implantation site.
Related Literature
Frequently Asked Questions
What is the vascular access port cath cat vp-xxxx used for?
It is used for providing long-term venous access for patients requiring frequent intravenous treatments, such as chemotherapy.
What specialties typically use this device?
Oncology and hematology specialists commonly use this device for managing patients with cancer or chronic blood disorders.
What are the FDA-cleared indications?
The device is indicated for patients needing long-term intravenous therapy, such as those undergoing chemotherapy or frequent blood transfusions.