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convey guiding catheter
Pendracare International
Summary: The convey guiding catheter by Pendracare International is a Class 2 medical device used primarily in venous stent procedures. Key evidence highlights its application in tumor embolization and hemodynamic therapy.
FDA Clearance Information
Pathway
510K
Number
K120585 ↗
Decision Date
August 8, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The convey guiding catheter received FDA clearance through the 510(k) pathway on August 8, 2012. It is manufactured by Pendracare International and classified as a Class 2 device.
What It Is
The convey guiding catheter is a medical device designed to facilitate the placement of venous stents. It is used in interventional procedures to guide other instruments to the target site within the vascular system.
Clinical Applications
Commonly used in procedures involving venous stenting, the convey guiding catheter is applicable in scenarios such as tumor embolization and management of complex congenital heart disease.
Evidence Summary
The literature includes 8 studies, comprising various types such as RCTs, prospective, and retrospective studies, published between 2020 and 2025. These studies explore the catheter's use in different clinical settings.
Reported Outcomes
Published studies report the convey guiding catheter's effectiveness in facilitating tumor embolization and improving outcomes in hemodynamic therapy for cardiogenic shock. Its use in accessing the pulmonary venous atrium in congenital heart disease has also been documented.
Safety Profile
Reported complications include challenges in accessing calcified surgical repair material and potential risks associated with the distal radial artery approach. No significant adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to establish comprehensive safety profiles and efficacy in broader patient populations.
Frequently Asked Questions
What are the clinical indications for convey guiding catheter?
The convey guiding catheter is indicated for use in venous stenting procedures, including tumor embolization and management of complex congenital heart disease.
What outcomes have been reported in clinical studies?
Studies have reported successful tumor embolization and improved hemodynamic outcomes in cardiogenic shock management.
What complications have been reported?
Safety data indicate potential complications with accessing calcified surgical repair material and risks associated with the distal radial artery approach.
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.