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shockwave cs guide catheter
Shockwave Medical.
Summary: The Shockwave CS Guide Catheter is a medical device used in venous stenting procedures. It is primarily utilized by interventional cardiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K243757 ↗
Decision Date
May 2, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Shockwave CS Guide Catheter was cleared via the FDA 510k pathway on May 2, 2025. It is manufactured by Shockwave Medical and is classified as a Class 2 device.
What It Is
The Shockwave CS Guide Catheter is a specialized catheter designed to facilitate the delivery of stents in venous procedures. It is engineered to provide enhanced support and precise navigation through the venous system, aiding in the placement of stents in challenging anatomical locations. The device leverages shockwave technology to assist in crossing calcified lesions, improving procedural success rates.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly for patients requiring venous stenting. It is suitable for use in hospitals and specialized cardiovascular centers. The catheter is beneficial for patients with venous obstructions or those undergoing complex stenting procedures, especially where calcified lesions are present.
Indications for Use
The Shockwave CS Guide Catheter is indicated for use in patients requiring venous stenting, particularly in cases where navigating through calcified or obstructed venous pathways is necessary. It is designed to assist in the delivery and placement of stents in the venous system.
Practical Considerations
The Shockwave CS Guide Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and requires familiarity with shockwave-assisted techniques. Proper training in its use is recommended to optimize outcomes.
Related Literature
The linked study, 'Single TriClip Steerable Guide for Combined MitraClip and TriClip Transcatheter Edge-to-Edge Repair (STriC-TEER): A Multicenter Experience,' explored the use of a steerable guide catheter in combined MitraClip and TriClip procedures. Although specific findings are not detailed, the study highlights the potential for using a single guide system in complex transcatheter repairs. Limitations include the lack of an available abstract and the need for further research to validate the findings.
Frequently Asked Questions
What is the Shockwave CS Guide Catheter used for?
It is used for facilitating venous stenting procedures, particularly in cases with calcified lesions.
What specialties typically use this device?
Interventional cardiologists and vascular specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for venous stenting, especially in cases requiring navigation through calcified or obstructed pathways.
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.