đź“‹ FDA Reference
psg tm edm tm infusion catheter
Peripheral Systems Group
Summary: The PSG TM EDM TM Infusion Catheter is a medical device used for delivering therapeutic agents directly into the venous system. It is primarily used by interventional radiologists and vascular surgeons in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K895932 ↗
Decision Date
January 4, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The PSG TM EDM TM Infusion Catheter was cleared through the FDA 510(k) pathway on January 4, 1990. Manufactured by Peripheral Systems Group, it is classified as a Class 2 device under product code DQY.
What It Is
The PSG TM EDM TM Infusion Catheter is a specialized catheter designed for the infusion of therapeutic agents into the venous system. It features a flexible, small-diameter tube that can be navigated through the vascular system to deliver medications or contrast agents directly to targeted areas. This device is particularly useful in procedures requiring precise delivery of substances within the venous system.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery for procedures such as chemotherapy infusion, thrombolysis, and delivery of contrast media during imaging studies. It is suitable for use in hospital settings, outpatient clinics, and specialized infusion centers. The device is typically used in adult patients requiring targeted venous therapy.
Indications for Use
The FDA indications suggest this device is intended for patients who require direct infusion of therapeutic agents into the venous system. It is particularly beneficial for conditions that necessitate localized drug delivery, such as certain cancers or vascular disorders.
Practical Considerations
The PSG TM EDM TM Infusion Catheter is available in various sizes to accommodate different vascular anatomies. It is compatible with standard infusion pumps and connectors. Clinicians should be trained in catheter placement techniques to ensure proper positioning and minimize complications.
Frequently Asked Questions
What is PSG TM EDM TM Infusion Catheter used for?
It is used for the direct infusion of therapeutic agents into the venous system, often in procedures like chemotherapy or thrombolysis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons are the primary users of this device.
What are the FDA-cleared indications?
The device is indicated for patients needing direct venous infusion of therapeutic agents, such as in cancer treatment or vascular interventions.
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.