đź“Š Evidence-Based Reference
Cardiovascular Custom Surgical Kit
Xanmed
Summary: The cardiovascular custom surgical kit by Xanmed is a Class 2 device cleared by the FDA for use in embolization procedures. Key evidence includes 12 studies examining various clinical outcomes and safety profiles.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844593 ↗
Decision Date ?
June 21, 1985
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The cardiovascular custom surgical kit was cleared through the FDA 510(k) pathway on June 21, 1985. It is manufactured by Xanmed and classified as a Class 2 device under product code DYB.
What It Is
The cardiovascular custom surgical kit is designed for use in embolization procedures, providing clinicians with a tailored set of tools for surgical interventions. It is intended to assist in the precise delivery of embolization coils.
FDA-Cleared Indications
- Use in embolization procedures requiring a cardiovascular custom surgical kit.
- Use to assist clinicians with the delivery of embolization coils during an indicated procedure.
Clinical Applications
- Supporting catheter-based embolization procedures.
- Assisting with delivery of embolization coils for vascular occlusion.
- Providing procedure-specific instruments for selected cardiovascular embolization interventions.
Evidence Summary
The available literature includes 12 studies, encompassing various study types such as RCTs and prospective trials, conducted between 2021 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varied outcomes, including improved procedural success rates and enhanced precision in embolization. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general surgical risks associated with embolization procedures, but specific adverse events related to the device are not detailed in the provided studies.
Evidence Limitations
The evidence lacks detailed efficacy metrics and specific safety data related to the device. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Practical Considerations
- The available record does not provide specific kit contents, catheter dimensions, coil sizes, or vessel size ranges; these should be verified in the device labeling and kit documentation.
- Compatibility with guidewires, microcatheters, delivery catheters, coils, and other embolic materials must be confirmed before use.
- Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and operator training in embolization procedures.
- MRI safety cannot be determined from the available FDA summary; individual components and any implanted embolic device require separate MRI-conditional or MRI-safety review.
- Contraindications, warnings, and handling instructions should be obtained from the current manufacturer labeling. Risks may include bleeding, infection, vessel injury, non-target embolization, ischemia, and device malfunction.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the cardiovascular custom surgical kit?
The device is indicated for use in embolization procedures, as detailed in the FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improved procedural success and precision in embolization, though specific metrics are not provided.
What complications have been reported?
Safety data from the studies do not specify device-related complications, focusing instead on general surgical risks.
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.