📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K962717 ↗
Decision Date ?
February 12, 1997
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for vascular access and catheter guidance during percutaneous interventional procedures.
- Available in 6, 7, and 8 French sizes for use with compatible guidewires, diagnostic catheters, and interventional devices.
Clinical Applications
- Providing vascular access during percutaneous endovascular procedures.
- Guiding or supporting the delivery of compatible catheters and devices within the vasculature.
- Supporting catheter-based vascular interventions when the selected catheter size and configuration are appropriate.
Reported off-label uses
- Use as an access or support catheter during complex peripheral venous interventions, including selected thrombectomy procedures.
- Use as a guiding catheter during venous stent delivery when the catheter is compatible with the stent system and intended anatomy.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The available sizes are 6, 7, and 8 French; the selected size must match the access sheath, guidewire, and interventional device requirements.
- Use fluoroscopic or other appropriate imaging guidance, with standard sterile technique and anticoagulation practices determined by the procedure.
- The phosphorylcholine coating is intended to improve surface biocompatibility, but it does not eliminate risks such as thrombosis, embolization, vessel injury, infection, or bleeding.
- MRI safety is not established from the provided FDA record. Confirm the current labeling and MRI conditions before exposing a catheter in or near an MRI environment.
- Do not use if the catheter, packaging, or coating is damaged, or when the patient has a contraindication to the planned vascular procedure or catheter materials.
Procedures that use this device
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.