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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 510K
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.
Clinical Applications
These applicator kits are commonly used in procedures involving the portal vein, such as embolization or targeted drug delivery. Interventional radiologists and vascular surgeons frequently utilize these kits in hospital settings, particularly for patients requiring localized treatment of liver conditions. The device is beneficial in managing conditions like portal hypertension or liver tumors where precise agent delivery is critical.
Indications for Use
The FDA-cleared indications for these kits involve their use in procedures targeting the portal vein. They are intended for patients requiring precise therapeutic delivery to the liver, often in cases of vascular abnormalities or localized liver disease.
Practical Considerations
The kits come in various sizes to accommodate different procedural needs and are compatible with standard interventional radiology equipment. Clinicians should be familiar with the technique of using drop applicators to ensure optimal delivery and avoid complications.
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.