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turbo support catheter
Datascope
Summary: The turbo support catheter by Datascope is a Class 2 medical device cleared by the FDA for use in venous stenting procedures. Key evidence highlights its role in improving procedural outcomes.
FDA Clearance Information
Pathway
510K
Number
K910116 ↗
Decision Date
June 25, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The turbo support catheter was cleared through the FDA 510(k) pathway on June 25, 1991. It is manufactured by Datascope and classified as a Class 2 device under product code DQY.
What It Is
The turbo support catheter is a medical device designed to facilitate the placement and support of venous stents. It is used in interventional procedures to ensure proper stent deployment and stability.
Clinical Applications
Commonly used in procedures involving venous stenting, the turbo support catheter aids in the accurate placement of stents, particularly in cases of venous obstruction or narrowing.
Evidence Summary
The literature includes 11 studies, encompassing various study designs such as RCTs and case series, published between 2021 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the use of the turbo support catheter in conjunction with other interventions, such as laser atherectomy and drug-coated balloon angioplasty, is associated with improved outcomes in treating femoropopliteal artery in-stent restenosis. The combination therapy has shown superior efficacy compared to conventional methods.
Safety Profile
Reported complications include concerns about thermal injury during procedures involving radiofrequency ablation, as noted in studies examining similar devices. However, specific safety data for the turbo support catheter itself is limited.
Evidence Limitations
The evidence base for the turbo support catheter is limited by the small number of studies directly evaluating its use. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
Frequently Asked Questions
What are the clinical indications for the turbo support catheter?
The turbo support catheter is indicated for use in venous stenting procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported improved outcomes when the turbo support catheter is used in combination with laser atherectomy and drug-coated balloon angioplasty for treating femoropopliteal artery in-stent restenosis.
What complications have been reported?
Safety data specific to the turbo support catheter is limited, but similar devices have reported complications such as thermal injury during radiofrequency ablation procedures.
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.