đź“Š Evidence-Based Reference
ballast 088 long sheath
Balt U
Summary: The Ballast 088 Long Sheath by Balt U is a device used in neuroendovascular procedures, particularly via transradial access. Key evidence highlights its safety and efficacy in such interventions.
FDA Clearance Information
Pathway
510K
Number
K182918 ↗
Decision Date
March 21, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Ballast 088 Long Sheath received FDA clearance through the 510(k) pathway on March 21, 2019. It is manufactured by Balt U and classified as a Class 2 device.
What It Is
The Ballast 088 Long Sheath is a medical device designed for use in neuroendovascular procedures. It facilitates access to the vascular system via the radial artery, allowing for the delivery of therapeutic devices.
Clinical Applications
Commonly used in neuroendovascular procedures, the Ballast 088 Long Sheath is employed in scenarios where transradial access is preferred over transfemoral access, offering benefits such as reduced recovery time and patient comfort.
Evidence Summary
The available literature includes two studies published between 2022 and 2025, focusing on the use of the Ballast 088 Long Sheath in neuroendovascular procedures. These studies include a multicenter investigation and an initial experience report.
Reported Outcomes
Published studies report that the Ballast 088 Long Sheath is effective in facilitating neuroendovascular procedures via transradial access. The studies highlight its utility in achieving successful vascular access and procedural outcomes.
Safety Profile
Reported complications include limited data on adverse events, as the studies primarily focus on procedural efficacy. Further research is needed to comprehensively assess safety outcomes.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is necessary to establish long-term safety and efficacy, as well as to explore broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Ballast 088 Long Sheath?
The device is indicated for use in neuroendovascular procedures, particularly those utilizing transradial access.
What outcomes have been reported in clinical studies?
Studies report successful procedural outcomes and effective vascular access using the Ballast 088 Long Sheath.
What complications have been reported?
The studies provide limited data on complications, indicating a need for further research to fully assess safety.
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.