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cordis webster ref-star ex surface reference device model s d-1204-01 -02 -03 and -04
Cordis Webster
Summary: The Cordis Webster Ref-Star Ex is a surface reference device used in tumor ablation procedures. It is primarily utilized by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K980961 ↗
Decision Date
May 28, 1998
Product Code
DRF
Device Class
Class 2
Evidence
0 studies
The Cordis Webster Ref-Star Ex was cleared via the FDA 510k pathway on May 28, 1998. It is manufactured by Cordis Webster and classified as a Class 2 medical device.
What It Is
The Cordis Webster Ref-Star Ex is a surface reference device designed for use in tumor ablation procedures. It assists in the accurate placement and monitoring of ablation devices, ensuring precise targeting of tumor tissues. This device is crucial for enhancing the efficacy and safety of ablation therapies by providing reliable reference points during the procedure.
Clinical Applications
This device is commonly used in interventional oncology, particularly for procedures involving the ablation of liver, kidney, or lung tumors. It is utilized in hospital settings, often in conjunction with imaging technologies such as CT or MRI, to guide the ablation process. The device is used by specialists such as interventional radiologists and oncologists to improve procedural outcomes for patients with solid tumors.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures where precise tumor ablation is required. It is suitable for patients with solid tumors that are accessible for ablation, providing a reference for accurate device placement.
Practical Considerations
The Cordis Webster Ref-Star Ex is available in multiple models, which may vary in size to accommodate different procedural needs. It is compatible with standard ablation equipment and imaging systems, and clinicians should ensure proper calibration and positioning for optimal results.
Related Literature
The linked study investigated the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes undergoing PCI. It found that short-term DAPT may be effective, but the study's focus on coronary interventions limits its direct applicability to tumor ablation contexts. The findings highlight the importance of tailored therapy durations based on individual patient risk profiles.
Frequently Asked Questions
What is the Cordis Webster Ref-Star Ex used for?
It is used as a surface reference device in tumor ablation procedures to ensure accurate targeting and monitoring.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings for tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise tumor ablation, providing reference points for accurate device placement.
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.