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E-Z-Flow Angiography Catheters Modification
E-Z-Em
Summary: The E-Z-Flow angiography catheters are used for diagnostic imaging in vascular procedures. Cleared by the FDA via 510(k) in 1992, they are supported by 10 studies focusing on their clinical applications and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K914984 ↗
Decision Date ?
May 20, 1992
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The E-Z-Flow angiography catheters were cleared by the FDA through the 510(k) pathway on May 20, 1992. Manufactured by E-Z-Em, they are classified as Class 2 devices.
What It Is
The E-Z-Flow angiography catheters are designed for use in angiographic procedures to visualize blood vessels. They facilitate the injection of contrast media into the vascular system, aiding in the diagnosis of vascular conditions.
FDA-Cleared Indications
- For percutaneous vascular catheterization and angiographic injection of contrast media to visualize blood vessels.
- For diagnostic angiographic procedures in which selective or nonselective delivery of contrast is required.
Clinical Applications
- Diagnostic angiography to visualize vascular anatomy and blood flow.
- Assessment of vessel patency or obstruction using injected contrast media.
- Contrast delivery during peripheral vascular angiography.
- Contrast delivery during coronary angiographic imaging when the catheter configuration and labeling are appropriate.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2024 and 2025. These studies explore the device's clinical utility and safety profile.
Reported Outcomes
Published studies report that the E-Z-Flow angiography catheters effectively facilitate vascular imaging, aiding in the diagnosis and management of coronary artery disease. They are noted for their role in optimizing stent placement and improving procedural outcomes.
Safety Profile
Reported complications include potential risks associated with angiographic procedures, such as vascular injury and contrast-induced nephropathy. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence base is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to fully understand the device's safety profile and efficacy in diverse patient populations.
Practical Considerations
- The FDA record does not provide specific catheter sizes, lengths, tip configurations, pressure limits, or guidewire compatibility; these details should be confirmed in the applicable product labeling.
- Use requires sterile vascular access, imaging guidance, and appropriate contrast-media administration technique.
- Potential complications include bleeding or hematoma at the access site, vessel injury, thrombosis, embolization, infection, contrast reaction, and kidney injury related to contrast exposure.
- MRI safety is not established from the information provided. Confirm MR Safe, MR Conditional, or MR Unsafe status for the exact catheter before MRI exposure.
- Contraindications and warnings may include inability to obtain safe vascular access, uncorrected significant bleeding risk, severe contrast allergy, or other patient-specific factors identified in the product labeling.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for E-Z-Flow angiography catheters?
The catheters are indicated for use in angiographic procedures to visualize blood vessels and assess vascular conditions.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of vascular imaging and improved procedural outcomes in coronary interventions.
What complications have been reported?
Safety data from studies indicate potential risks such as vascular injury and contrast-induced nephropathy.
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.