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catheter introducers arterise
C.R. Bard
Summary: Catheter introducers arterise by C.R. Bard are used in vascular access procedures. Cleared by FDA in 1978, they are involved in embolization-coils clinical categories. Key evidence highlights their role in pressure waveform fidelity and flow rate management.
FDA Clearance Information
Pathway
510K
Number
K781954 ↗
Decision Date
November 29, 1978
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducers arterise by C.R. Bard were cleared through the FDA 510k pathway on November 29, 1978. They are classified as Class 2 devices under product code DYB.
What It Is
Catheter introducers arterise are medical devices designed to facilitate the insertion of catheters into the vascular system. They are primarily used in procedures requiring vascular access, such as embolization-coils interventions.
Clinical Applications
These introducers are commonly used in interventional cardiology and radiology for procedures that require precise catheter placement, such as transcatheter aortic valve replacement and endovascular aneurysm repair.
Evidence Summary
The literature includes 9 studies ranging from 1985 to 2024, encompassing various study types such as RCTs and case series. These studies explore aspects like pressure wave fidelity and flow rate in catheter introducers.
Reported Outcomes
Published studies report that catheter introducers arterise maintain pressure waveform fidelity and manage flow rates effectively. They are shown to support accurate blood pressure measurements and facilitate large bore access in complex procedures.
Safety Profile
Reported complications include risks associated with large bore access, such as thrombosis and limb ischemia. These are critical considerations for clinicians using the device in interventional procedures.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of recent large-scale trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for catheter introducers arterise?
The device is indicated for use in vascular access procedures, particularly in interventional cardiology and radiology.
What outcomes have been reported in clinical studies?
Studies report effective pressure waveform fidelity and flow rate management, supporting accurate measurements and successful large bore access.
What complications have been reported?
Safety data indicate risks of thrombosis and limb ischemia associated with large bore access.
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.