đź“‹ FDA Reference
infusion catheter w side holes
Target Therapeutics
Summary: The infusion catheter with side holes by Target Therapeutics is a medical device used to deliver fluids directly into blood vessels. It is primarily used by interventional radiologists and vascular surgeons in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K854000 ↗
Decision Date
November 5, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 5, 1985. Manufactured by Target Therapeutics, it is classified as a Class 2 medical device under product code DQY.
What It Is
The infusion catheter with side holes is designed to deliver therapeutic agents directly into the vascular system. The side holes allow for even distribution of fluids, which can include medications, contrast agents, or other therapeutic substances. This design helps in achieving targeted delivery, minimizing systemic exposure and potential side effects.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this catheter is employed in procedures requiring precise delivery of agents into blood vessels. It is particularly useful in treating vascular conditions such as thrombosis or in procedures like chemoembolization. The device is suitable for use in hospital settings, especially in patients requiring targeted vascular interventions.
Indications for Use
The FDA indications suggest this catheter is used for delivering fluids directly into the vascular system. It is suitable for patients needing localized treatment of vascular conditions, such as those with blockages or requiring targeted drug delivery.
Practical Considerations
These catheters come in various sizes to accommodate different vessel diameters and patient needs. Compatibility with other vascular access devices should be considered. Proper technique in insertion and positioning is crucial to ensure effective delivery and minimize complications.
Frequently Asked Questions
What is the infusion catheter with side holes used for?
It is used for delivering therapeutic agents directly into blood vessels, often in procedures requiring precise and localized treatment.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device in various vascular interventions.
What are the FDA-cleared indications?
The catheter is indicated for the delivery of fluids directly into the vascular system for patients needing targeted vascular treatment.
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.