đź“‹ FDA Reference
multi-port y introducer set
Thomas Medical Products
Summary: The multi-port Y introducer set is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists during procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K931587 ↗
Decision Date
October 6, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The multi-port Y introducer set by Thomas Medical Products was cleared via the FDA 510(k) pathway on October 6, 1993. It is classified as a Class 2 device under product code DYB.
What It Is
The multi-port Y introducer set is a device designed to provide access to the vascular system, allowing for the insertion and exchange of catheters and other medical devices. It typically consists of a sheath and dilator, with a Y-shaped configuration that permits simultaneous access through multiple ports. This design facilitates complex procedures by allowing for the introduction of various instruments without repeated vascular punctures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angioplasty, and catheter-based diagnostics. It is particularly useful in settings where multiple devices need to be introduced into the vascular system, such as during the placement of embolization coils. Patients undergoing these procedures often have conditions like vascular malformations or coronary artery disease.
Indications for Use
The FDA-cleared indications for the multi-port Y introducer set include its use in procedures requiring vascular access for the insertion of catheters and other medical devices. It is suitable for patients needing interventions like embolization or other catheter-based therapies.
Practical Considerations
When using the multi-port Y introducer set, clinicians should consider the appropriate sizing to match the patient's vascular anatomy and the devices being introduced. Compatibility with other medical devices should be verified, and care should be taken to maintain sterility during insertion. Familiarity with the technique for sheath insertion and device exchange is essential for optimal outcomes.
Frequently Asked Questions
What is the multi-port Y introducer set used for?
It is used to facilitate the insertion and exchange of catheters and other devices into the vascular system during procedures like embolization and angioplasty.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for the insertion of catheters and other medical devices.
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.