đź“Š Evidence-Based Reference
vasco tip vascoflange
Vascor Medical
Summary: The vasco tip vascoflange by Vascor Medical is an IVC filter device, primarily used to prevent pulmonary embolism. Key evidence findings are not available from the provided studies.
FDA Clearance Information
Pathway
510K
Number
K913831 ↗
Decision Date
August 25, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The vasco tip vascoflange received FDA clearance through the 510(k) pathway on August 25, 1993. It is manufactured by Vascor Medical and classified as a Class III device.
What It Is
The vasco tip vascoflange is an inferior vena cava (IVC) filter designed to prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. It is intended for use in patients at risk of thromboembolic events.
Clinical Applications
This device is commonly used in clinical scenarios where patients are at high risk for pulmonary embolism and anticoagulation therapy is contraindicated or ineffective. It is typically deployed in the inferior vena cava to capture emboli.
Evidence Summary
The available literature includes 10 studies, though none directly pertain to the vasco tip vascoflange. The studies span various years and cover different topics unrelated to this device.
Reported Outcomes
Published studies report no specific efficacy findings for the vasco tip vascoflange, as the provided evidence does not include relevant clinical trials or outcomes related to this device.
Safety Profile
Reported complications include no specific safety data for the vasco tip vascoflange, as the provided evidence does not address adverse events or complications associated with this device.
Evidence Limitations
The evidence lacks direct studies on the vasco tip vascoflange, highlighting a significant gap in clinical data. Further research is needed to evaluate its efficacy and safety in real-world settings.
Frequently Asked Questions
What are the clinical indications for vasco tip vascoflange?
The vasco tip vascoflange is indicated for preventing pulmonary embolism in patients where anticoagulation is not suitable.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the provided evidence for the vasco tip vascoflange.
What complications have been reported?
No specific complications have been reported in the provided evidence for the vasco tip vascoflange.
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.