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6 french 7 french and 8 french guiding catheters with phosphorylcholine pc polymer coating
Biocompatibles Cardiovascular
Summary: The guiding catheters by Biocompatibles Cardiovascular are used for vascular access in interventional procedures. They feature a phosphorylcholine polymer coating to enhance biocompatibility. No specific outcomes or safety data are available from the provided studies.
FDA Clearance Information
Pathway
510K
Number
K962717 ↗
Decision Date
February 12, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheters were cleared by the FDA through the 510(k) pathway on February 12, 1997. Manufactured by Biocompatibles Cardiovascular, they are classified as Class 2 devices under product code DQY.
What It Is
These guiding catheters are designed for vascular access during interventional procedures. They are coated with phosphorylcholine polymer to improve biocompatibility and reduce thrombogenicity. Intended for use in venous stenting and other vascular interventions.
Clinical Applications
Commonly used in procedures requiring vascular access, such as coronary angiography and stenting. The phosphorylcholine coating is intended to minimize complications related to thrombosis and inflammation.
Evidence Summary
The literature includes 15 studies, though none specifically address the guiding catheters. The studies range from 2022 to 2024 and cover various topics unrelated to the device.
Reported Outcomes
Published studies report no specific outcomes related to the guiding catheters. The available evidence does not provide data on efficacy or performance in clinical settings.
Safety Profile
Reported complications include no specific safety data related to the guiding catheters. The studies provided do not address adverse events or complications associated with these devices.
Evidence Limitations
The evidence lacks direct studies on the guiding catheters, with no specific data on clinical outcomes or safety. Further research is needed to evaluate the device's performance and safety profile in clinical practice.
Frequently Asked Questions
What are the clinical indications for guiding catheters?
The guiding catheters are indicated for use in vascular access during interventional procedures, such as venous stenting.
What outcomes have been reported in clinical studies?
No specific outcomes related to the guiding catheters are reported in the provided studies.
What complications have been reported?
The provided evidence does not report any complications related to the guiding catheters.
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.