đź“‹ FDA Reference
over the needle splitable catheter assembly type 1
Teleflexmedical
Summary: The over the needle splitable catheter is a medical device used for vascular access, typically in interventional radiology or cardiology. It is used by healthcare professionals to facilitate procedures requiring catheterization.
FDA Clearance Information
Pathway
510K
Number
K920908 ↗
Decision Date
October 6, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on October 6, 1992. Manufactured by Teleflexmedical, it is classified as a Class 2 device under product code DYB.
What It Is
The over the needle splitable catheter is a type of catheter assembly designed for easy insertion into the vascular system. It features a needle that aids in the initial puncture and a splitable sheath that allows for the catheter to be placed securely. This design helps in minimizing trauma to the vessel and facilitates smoother catheter placement.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as the placement of embolization coils in interventional radiology. It is suitable for use in both hospital and outpatient settings, and is typically employed by specialists in cardiology, radiology, and vascular surgery. The device is particularly useful in patients requiring precise catheter placement for diagnostic or therapeutic interventions.
Indications for Use
The FDA indications suggest this device is intended for use in procedures that require vascular access, such as embolization. It is suitable for patients needing interventions that involve the introduction of devices or medications into the vascular system.
Practical Considerations
Clinicians should consider the appropriate size of the catheter based on the patient's vascular anatomy. The device is compatible with standard vascular access techniques and should be used by trained professionals familiar with catheterization procedures.
Frequently Asked Questions
What is the over the needle splitable catheter used for?
It is used for vascular access in procedures like embolization, where precise catheter placement is required.
What specialties typically use this device?
Specialties such as interventional radiology, cardiology, and vascular surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as the placement of embolization coils.
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.