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cordis introducer guide
Cordis
Summary: The Cordis Introducer Guide is a medical device used primarily for venous stenting procedures. It has been FDA-cleared via the 510(k) pathway. Key evidence includes studies on its use in complex vascular procedures.
FDA Clearance Information
Pathway
510K
Number
K001136 ↗
Decision Date
April 28, 2000
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis Introducer Guide was cleared by the FDA through the 510(k) pathway on April 28, 2000. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Cordis Introducer Guide is designed to facilitate the introduction of catheters and other devices into the venous system. It is primarily used in procedures requiring venous access, such as stenting.
Clinical Applications
Common clinical scenarios for the Cordis Introducer Guide include venous stenting and other vascular interventions where precise catheter placement is necessary. It is often used in conjunction with other devices for complex vascular access.
Evidence Summary
The available literature includes four studies ranging from 1993 to 2022. These studies encompass various types of research, including retrospective and prospective analyses, focusing on the device's application in vascular procedures.
Reported Outcomes
Published studies report successful use of the Cordis Introducer Guide in complex vascular procedures, including coronary angioplasty and intracranial stenting. Outcomes indicate feasibility and technical success in these applications.
Safety Profile
Reported complications include potential vascular spasm and pain when larger introducer sheaths are used, as noted in studies involving distal transradial artery access. Accidental arterial cannulation is also a noted risk in central venous access procedures.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Cordis Introducer Guide?
The Cordis Introducer Guide is indicated for use in venous stenting and other vascular access procedures requiring precise catheter placement.
What outcomes have been reported in clinical studies?
Studies report successful technical outcomes in procedures like coronary angioplasty and intracranial stenting, demonstrating the device's feasibility.
What complications have been reported?
Safety data indicate risks of vascular spasm, pain, and accidental arterial cannulation during certain procedures.
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.