📊 Evidence-Based Reference
Concentroc HD Guide Catheter Models 90017 4f 90019 5f 90021 6f 90022 7f 90023 8f 90024 9f
Concentric Medical
Summary: The Concentroc HD Guide Catheter, manufactured by Concentric Medical, is used in venous stent procedures. Key evidence includes studies on endovascular models and imaging modalities.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003880 ↗
Decision Date ?
May 16, 2001
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Concentroc HD Guide Catheter received FDA clearance via the 510(k) pathway on May 16, 2001. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The Concentroc HD Guide Catheter is a medical device designed for use in venous stent procedures. It facilitates the delivery of stents to targeted vascular sites, aiding in the treatment of vascular conditions.
FDA-Cleared Indications
- Percutaneous catheter use for vascular access and guidance during endovascular procedures.
- Use in accordance with the catheter's labeling, compatible devices, and the treating physician's clinical judgment.
Clinical Applications
- Providing a conduit for the introduction and positioning of compatible interventional devices.
- Catheter-based access to selected peripheral or central vascular anatomy during image-guided procedures.
Evidence Summary
The available literature includes 10 studies, ranging from randomized controlled trials to systematic reviews, published between 2023 and 2025. These studies explore various aspects of endovascular procedures and imaging techniques.
Reported Outcomes
Published studies report advancements in catheter-based procedures, including improved stent placement accuracy and reduced procedural invasiveness. Studies highlight the catheter's role in facilitating complex endovascular interventions.
Safety Profile
Reported complications include procedural challenges such as catheter navigation difficulties and potential vascular injury. However, the studies emphasize the device's overall safety profile in clinical settings.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for further research on long-term outcomes. Additional studies are required to fully understand the device's efficacy across diverse patient populations.
Practical Considerations
- Models are available in 4F, 5F, 6F, 7F, 8F, and 9F sizes; the selected size must match the access site, anatomy, guidewire, and device being delivered.
- The catheter should be used with compatible guidewires, introducers, and interventional devices according to the manufacturer's instructions.
- Vascular access and catheter manipulation should be performed with appropriate fluoroscopic or other intravascular imaging guidance by trained clinicians.
- The available FDA record does not establish MRI safety; MRI compatibility should be confirmed in the current manufacturer labeling before scanning.
- Potential complications include bleeding, hematoma, vascular injury, thrombosis, embolization, infection, contrast reaction, and catheter damage or entrapment.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Concentroc HD Guide Catheter?
The device is indicated for use in venous stent procedures, aiding in the delivery and placement of stents within the vascular system.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in stent placement and reduced invasiveness of procedures using the catheter.
What complications have been reported?
Safety data indicate potential complications such as catheter navigation difficulties and vascular injury, though overall safety is affirmed.
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.