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support catheter
Qxmedical
Summary: The support catheter by Qxmedical is used primarily in venous stent procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on its use in peripheral chronic total occlusions and pulmonary embolism management.
FDA Clearance Information
Pathway
510K
Number
K200317 ↗
Decision Date
May 14, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The support catheter by Qxmedical was cleared by the FDA through the 510k pathway on May 14, 2020. It is classified as a Class 2 device under product code DQY.
What It Is
The support catheter is a medical device designed to assist in the placement and support of other catheters during endovascular procedures. It is primarily used in venous stenting and other vascular interventions.
Clinical Applications
Common clinical scenarios for the support catheter include its use in procedures involving venous stents, such as treating peripheral chronic total occlusions and managing intermediate-risk pulmonary embolism.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to case series, published between 2020 and 2023. These studies explore various clinical applications and outcomes of the support catheter.
Reported Outcomes
Published studies report that the support catheter is effective in improving procedural success rates in endovascular treatments, particularly in peripheral chronic total occlusions. It has also been used in managing intermediate-risk pulmonary embolism with promising results.
Safety Profile
Reported complications include mechanical issues related to catheter placement and potential hemodynamic instability during procedures. However, specific adverse events are not detailed in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to establish standardized protocols and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for support catheter?
The support catheter is indicated for use in venous stenting procedures, particularly in peripheral chronic total occlusions and intermediate-risk pulmonary embolism management.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates in endovascular treatments, especially in peripheral chronic total occlusions.
What complications have been reported?
Reported complications include mechanical issues during catheter placement and potential hemodynamic instability, though specific adverse events are not detailed.
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.