đź“‹ FDA Reference
Thermogenesis Drop Applicator Kits Spray Kits and TIPS
Thermogenesis
Summary: The Thermogenesis Drop Applicator Kits are used for precise application of therapeutic agents in portal vein procedures. Typically utilized by interventional radiologists and vascular surgeons, these kits aid in targeted treatment delivery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K955282 ↗
Decision Date ?
May 6, 1996
Product Code ?
FMF
Device Class ?
Class 2
Evidence ?
0 studies
The Thermogenesis Drop Applicator Kits were cleared through the FDA 510(k) pathway on May 6, 1996, by Thermogenesis. It is a Class 2 medical device under product code FMF.
What It Is
The Thermogenesis Drop Applicator Kits consist of spray kits and tips designed for the precise application of therapeutic agents. These devices facilitate controlled delivery of substances directly into the portal vein, enhancing treatment accuracy. The kits are engineered to ensure compatibility with standard interventional equipment, providing ease of use in clinical settings.
FDA-Cleared Indications
- Used for the controlled application of therapeutic agents during procedures involving the portal vein.
- Intended to facilitate targeted delivery of therapeutic substances through an interventional catheter system.
- For use by qualified clinicians in procedures requiring localized application of an agent within the portal venous system.
Clinical Applications
- Controlled delivery of therapeutic agents during portal vein interventions.
- Targeted application of an agent within the portal venous system under imaging guidance.
- Use with compatible interventional equipment during procedures requiring precise intravascular delivery.
Practical Considerations
- The available FDA record does not specify the complete range of kit sizes, spray-tip configurations, or compatible catheter systems; clinicians should consult the current device labeling.
- Use requires training in portal venous access, catheter handling, and controlled delivery of the selected therapeutic agent.
- The risks of the procedure include bleeding, infection, vascular injury, non-target delivery, thrombosis, and complications related to the therapeutic agent.
- MRI safety cannot be determined from the available FDA summary. Confirm the labeling for each kit component before MRI exposure.
- Contraindications and precautions depend on the device components, access route, and therapeutic agent used; follow current manufacturer instructions and institutional protocol.
Frequently Asked Questions
What is Thermogenesis Drop Applicator Kits used for?
They are used for the precise application of therapeutic agents in portal vein procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The kits are indicated for use in procedures involving the portal vein, such as targeted drug delivery or embolization.
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.