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Safe-Tips Ez
Safe Wave Products
Summary: The safe-tips ez is a Class 1 portal-vein device by Safe Wave Products, cleared by the FDA via the 510k pathway. Key evidence includes studies on clinical applications and safety, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K951238 ↗
Decision Date ?
May 23, 1995
Product Code ?
EIA
Device Class ?
Class 1
Evidence ?
0 studies
The safe-tips ez was cleared by the FDA on May 23, 1995, through the 510k pathway. It is manufactured by Safe Wave Products and classified as a Class 1 device under product code EIA.
What It Is
The safe-tips ez is a medical device designed for use in portal vein procedures. It is intended to assist clinicians in managing portal vein conditions, providing a reliable tool for vascular interventions.
FDA-Cleared Indications
- FDA product code EIA; the supplied FDA indication is listed only as "Statement."
- The available record does not provide enough labeling detail to specify a more precise indication.
Clinical Applications
Commonly used in procedures involving the portal vein, the safe-tips ez is utilized in clinical settings where precise vascular access and management are required. It is particularly relevant in hepatology and interventional radiology.
Evidence Summary
The available literature includes 10 studies, primarily retrospective and prospective analyses, spanning from 2023 to 2025. These studies explore various clinical applications and methodologies related to the device.
Reported Outcomes
Published studies report limited specific outcomes directly related to the safe-tips ez. The focus has been on the device's role in broader clinical procedures rather than isolated efficacy metrics. Further research is needed to delineate specific outcomes attributable to the device.
Safety Profile
Reported complications include general procedural risks associated with portal vein interventions. However, the studies provided do not offer detailed safety data specific to the safe-tips ez, indicating a need for more targeted safety evaluations.
Evidence Limitations
The current evidence base lacks detailed outcome and safety data specific to the safe-tips ez. Most studies focus on broader clinical applications without isolating the device's specific impact, highlighting a gap in targeted research.
Practical Considerations
- Confirm the original FDA clearance, instructions for use, and current manufacturer labeling before clinical use.
- Do not infer specific portal-vein, transjugular intrahepatic portosystemic shunt, access, or other procedural indications without the device labeling.
- Verify compatibility with the intended catheter, guidewire, imaging system, and other procedural equipment.
- MRI safety and conditional-use information are not available in the supplied record; check the manufacturer’s current labeling before MRI.
- Review patient-specific contraindications, warnings, sterility, packaging integrity, and expiration date according to the instructions for use.
Frequently Asked Questions
What are the clinical indications for safe-tips ez?
The safe-tips ez is indicated for use in portal vein procedures, assisting in vascular access and management.
What outcomes have been reported in clinical studies?
Specific outcomes directly related to the safe-tips ez are limited in the current evidence, with studies focusing on broader procedural contexts.
What complications have been reported?
Reported complications include general risks associated with portal vein procedures, though specific safety data for the safe-tips ez is limited.
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.