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medtronic c315 delivery catheter
Medtronic
Summary: The Medtronic C315 delivery catheter is a device used primarily for the implantation of pacemakers in patients with challenging venous anatomy. Key evidence includes case reports highlighting its use in patients with anatomical anomalies.
FDA Clearance Information
Pathway
510K
Number
K101885 ↗
Decision Date
September 9, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic C315 delivery catheter was cleared by the FDA through the 510(k) pathway on September 9, 2010. It is manufactured by Medtronic and classified as a Class 2 device under product code DQY.
What It Is
The Medtronic C315 delivery catheter is a medical device designed to facilitate the delivery and implantation of pacemaker leads in patients with complex venous anatomy. It is intended for use in clinical settings where traditional approaches may be challenging.
Clinical Applications
This device is commonly used in scenarios where patients have anatomical anomalies such as persistent left superior vena cava or enlarged right atrium, which complicate standard pacemaker implantation procedures.
Evidence Summary
The available literature includes two studies: a case report from 2024 and another study from 2021. These studies focus on the use of delivery catheters in patients with unique anatomical challenges.
Reported Outcomes
Published studies report successful pacemaker implantation in patients with complex venous anatomy using the Medtronic C315 delivery catheter. The case report highlights its efficacy in overcoming anatomical challenges that hinder traditional implantation methods.
Safety Profile
Reported complications include challenges in deployment due to anatomical anomalies, as noted in the case studies. However, specific adverse events or complications directly related to the device were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited to case reports and lacks large-scale randomized controlled trials. Further research is needed to establish broader efficacy and safety profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic C315 delivery catheter?
The device is indicated for use in the implantation of pacemaker leads in patients with complex venous anatomy, such as those with persistent left superior vena cava.
What outcomes have been reported in clinical studies?
Studies report successful pacemaker implantation in patients with challenging venous anatomy using the Medtronic C315 delivery catheter.
What complications have been reported?
Reported complications include difficulties in deployment due to anatomical anomalies, but specific adverse events related to the device were not detailed in the studies.
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.