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vascoscrew 6 60 and vascoscrew 8 60
Vascor Medical
Summary: The vascoscrew 6 60 and 8 60 are devices used in the placement of IVC filters. They are FDA-cleared and primarily used in vascular procedures. Key evidence findings are not directly available from the provided studies.
FDA Clearance Information
Pathway
510K
Number
K914121 ↗
Decision Date
August 24, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The vascoscrew devices were cleared through the FDA 510(k) pathway on August 24, 1993. Manufactured by Vascor Medical, they are classified as Class III devices.
What It Is
The vascoscrew devices are surgical tools designed for the placement of inferior vena cava (IVC) filters. They are intended for use in vascular procedures to prevent pulmonary embolism by capturing blood clots.
Clinical Applications
Commonly used in patients at risk of pulmonary embolism, the vascoscrew devices assist in the placement of IVC filters. They are typically utilized in interventional radiology or vascular surgery settings.
Evidence Summary
The available literature includes 10 studies, though none directly pertain to the vascoscrew devices. The studies span various years and topics, indicating a need for more targeted research on these devices.
Reported Outcomes
Published studies report no specific efficacy findings related to the vascoscrew devices, as the provided evidence does not directly address these tools. Further research is needed to establish clinical outcomes.
Safety Profile
Reported complications include no specific safety data related to the vascoscrew devices from the provided studies. Safety profiles remain undetermined due to lack of direct evidence.
Evidence Limitations
The primary limitation is the absence of direct studies on the vascoscrew devices. Current evidence does not provide insights into their efficacy or safety, highlighting a need for dedicated research.
Frequently Asked Questions
What are the clinical indications for vascoscrew devices?
The vascoscrew devices are indicated for use in the placement of IVC filters to prevent pulmonary embolism.
What outcomes have been reported in clinical studies?
Specific outcomes for vascoscrew devices are not reported in the provided evidence.
What complications have been reported?
No specific complications related to vascoscrew devices are reported in the provided evidence.
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.