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Cordis Introducing Catheter
Summary: The Cordis Introducing Catheter is a device used for embolization procedures, particularly with embolization coils. Key evidence highlights its application in neuroendovascular treatments and tumor embolization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K945524 ↗
Decision Date ?
April 26, 1995
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis Introducing Catheter was cleared by the FDA via the 510(k) pathway on April 26, 1995. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Cordis Introducing Catheter is designed to facilitate the delivery of embolization coils in endovascular procedures. It is used in clinical settings for precise catheterization and embolization of targeted vessels.
FDA-Cleared Indications
- Used to facilitate the delivery of embolization coils during endovascular embolization procedures.
Clinical Applications
- Delivery of embolization coils to a targeted blood vessel.
- Catheter access during endovascular treatment of selected vascular lesions when coil embolization is indicated.
- Selective catheterization as part of an interventional radiology or neuroendovascular embolization procedure.
Reported off-label uses
- Use as an access or delivery catheter for embolic materials other than coils, when clinically appropriate.
- Selective delivery of embolic agents during tumor or vascular-malformation embolization, depending on the catheter's size and configuration.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of case reports and studies focusing on embolization techniques. The studies span from 2023 to 2025, highlighting various clinical applications and outcomes.
Reported Outcomes
Published studies report successful use of the Cordis Introducing Catheter in tumor embolization and neuroendovascular procedures. The device has been shown to facilitate effective embolization with minimal complications in reported cases.
Safety Profile
Reported complications include potential risks associated with catheterization, such as vessel injury or embolic events. However, the studies reviewed did not highlight significant adverse events directly linked to the catheter itself.
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 establish long-term outcomes and safety profiles in diverse patient populations.
Practical Considerations
- The catheter must be matched with compatible guidewires, introducer sheaths, embolization coils, and other delivery equipment.
- Available dimensions, distal-tip configuration, and working length should be confirmed in the current manufacturer documentation before use.
- The procedure is performed with fluoroscopic or other appropriate imaging guidance, using sterile technique and contrast when needed.
- MRI safety depends on the exact catheter model and whether it remains in the body; consult current labeling before MRI examination.
- Contraindications and precautions include inability to safely access the target vessel, significant vascular injury risk, contrast allergy when contrast is required, and patient-specific bleeding or clotting concerns.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Cordis Introducing Catheter?
The catheter is indicated for use in embolization procedures, particularly in neuroendovascular treatments and tumor embolization.
What outcomes have been reported in clinical studies?
Studies have reported successful embolization outcomes with minimal complications, particularly in neuroendovascular and tumor embolization procedures.
What complications have been reported?
Safety data from evidence indicate potential risks such as vessel injury or embolic events, though significant adverse events directly linked to the catheter are not highlighted.
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.