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vascotwist 9 60
Vascor Medical
Summary: The vascotwist 9 60 is an IVC filter used to prevent pulmonary embolism. It is FDA 510k cleared and linked to 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K920662 ↗
Decision Date
November 24, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The vascotwist 9 60, manufactured by Vascor Medical, received FDA 510k clearance on November 24, 1993. It is classified as a Class III device under product code DTB.
What It Is
The vascotwist 9 60 is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients with contraindications to anticoagulation therapy or those who have experienced recurrent venous thromboembolism despite anticoagulation. It is placed in the inferior vena cava to intercept emboli.
Evidence Summary
The available literature includes 10 studies, though specific details on study types, sample sizes, and outcomes are not provided. The studies span from 2022 to 2025.
Reported Outcomes
Published studies report limited specific outcomes related to the vascotwist 9 60. The evidence provided does not detail efficacy findings directly associated with this device.
Safety Profile
Reported complications include limited safety data as the provided evidence does not specify adverse events directly linked to the vascotwist 9 60.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the vascotwist 9 60. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for vascotwist 9 60?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
The provided evidence does not specify outcomes directly related to the vascotwist 9 60.
What complications have been reported?
Safety data specific to the vascotwist 9 60 is not detailed 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.