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11f guiding catheter
Boston Scientific /International Technologies
Summary: The 11f guiding catheter is a medical device used primarily in venous stent procedures. Key evidence highlights its application in pulmonary angioscopy and femoral artery procedures.
FDA Clearance Information
Pathway
510K
Number
K963663 ↗
Decision Date
January 13, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 11f guiding catheter was cleared by the FDA through the 510(k) pathway on January 13, 1997. It is manufactured by Boston Scientific/International Technologies and classified as a Class 2 device.
What It Is
The 11f guiding catheter is a medical device designed for use in venous stent procedures. It facilitates the navigation and placement of stents within the venous system, aiding in the treatment of vascular conditions.
Clinical Applications
Commonly used in procedures involving the pulmonary artery and femoral artery, the 11f guiding catheter assists in the precise placement of stents and other interventions during cardiac catheterization and related procedures.
Evidence Summary
The available literature includes four studies ranging from 1988 to 2021, encompassing various study types such as RCTs and case series. These studies explore the catheter's application in different clinical scenarios.
Reported Outcomes
Published studies report the successful use of the 11f guiding catheter in pulmonary angioscopy and femoral artery procedures. The device has been shown to facilitate effective stent placement and improve procedural outcomes in these contexts.
Safety Profile
Reported complications include issues related to the catheter's performance in specific scenarios, such as cervical spine immobilization. However, overall safety data from the studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to fully understand the device's efficacy and safety across a broader range of clinical applications.
Frequently Asked Questions
What are the clinical indications for 11f guiding catheter?
The 11f guiding catheter is indicated for use in venous stent procedures, particularly in the pulmonary and femoral arteries.
What outcomes have been reported in clinical studies?
Studies have reported successful stent placement and improved procedural outcomes in pulmonary angioscopy and femoral artery procedures.
What complications have been reported?
Safety data indicate potential performance issues in specific scenarios, such as cervical spine immobilization, but comprehensive safety data are 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.