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silvertorque visceral catheter
Surgimed
Summary: The Silvertorque Visceral Catheter by Surgimed is a Class 2 medical device cleared by the FDA for use in venous stenting procedures. Key evidence highlights its role in managing visceral artery conditions.
FDA Clearance Information
Pathway
510K
Number
K840761 ↗
Decision Date
June 11, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Silvertorque Visceral Catheter was cleared through the FDA 510(k) pathway on June 11, 1984. Manufactured by Surgimed, it is classified as a Class 2 device under product code DQY.
What It Is
The Silvertorque Visceral Catheter is designed for use in venous stenting procedures, particularly in the management of visceral artery conditions. It facilitates the placement of stents in complex vascular anatomies.
Clinical Applications
Commonly used in procedures involving visceral artery aneurysms and hemorrhages, the Silvertorque Visceral Catheter assists in the precise delivery of stents, enhancing procedural success in vascular interventions.
Evidence Summary
The available literature includes 9 studies, with a mix of RCTs, prospective, and retrospective analyses, spanning from 2020 to 2025. These studies explore various aspects of catheter use in visceral interventions.
Reported Outcomes
Published studies report the successful use of the Silvertorque Visceral Catheter in managing visceral artery hemorrhages and aneurysms. Technical success and improved procedural outcomes have been noted in several cases.
Safety Profile
Reported complications include potential adverse events related to catheter placement, such as vascular injury or occlusion. However, specific safety data from the studies provided is limited.
Evidence Limitations
The evidence base is limited by a lack of large-scale RCTs and comprehensive safety data. Further research is needed to fully understand long-term outcomes and potential complications associated with the device.
Frequently Asked Questions
What are the clinical indications for Silvertorque Visceral Catheter?
The device is indicated for use in venous stenting procedures, particularly in the management of visceral artery conditions.
What outcomes have been reported in clinical studies?
Studies report technical success in stent placement and improved procedural outcomes in managing visceral artery hemorrhages and aneurysms.
What complications have been reported?
Reported complications include potential vascular injury or occlusion related to catheter placement, though specific safety data is limited.
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.