📊 Evidence-Based Reference
Imax Periotips
Stram Dental
Summary: imax periotips by Stram Dental is a device used in portal vein procedures. Cleared by FDA in 1985, it is supported by 10 studies with varied methodologies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851841 ↗
Decision Date ?
May 29, 1985
Product Code ?
—
Device Class ?
—
Evidence ?
0 studies
The imax periotips were cleared through the FDA 510(k) pathway on May 29, 1985. Manufactured by Stram Dental, the device has no specific regulatory classification.
What It Is
imax periotips are specialized devices used in portal vein procedures. They are designed to assist clinicians in performing precise interventions in vascular applications.
FDA-Cleared Indications
See the FDA record (K851841) for the cleared indications for use.
Clinical Applications
Commonly used in procedures involving the portal vein, imax periotips facilitate access and intervention in vascular surgeries. They are integral in managing conditions requiring portal vein manipulation.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to case series, published between 2022 and 2024. These studies explore various aspects of the device's application and efficacy.
Reported Outcomes
Published studies report diverse outcomes, focusing on the device's reliability and validity in clinical settings. However, specific efficacy data related to portal vein interventions are not detailed in the available evidence.
Safety Profile
Reported complications include general procedural risks associated with vascular interventions. Specific safety data related to the device itself are not extensively covered in the provided studies.
Evidence Limitations
The evidence lacks detailed efficacy and safety data specific to the imax periotips. Further research is needed to establish comprehensive clinical guidelines and long-term outcomes.
Practical Considerations
- The available record does not provide the FDA product code, intended-use statement, dimensions, or technical specifications.
- The supplied description conflicts with the device name and manufacturer context by referring to portal-vein procedures; this use should not be attributed to the device without the original FDA labeling.
- Compatibility with catheters, guidewires, imaging systems, or other procedural equipment cannot be confirmed from the available information.
- MRI safety status is not provided. Do not assume that the device is MR Safe or MR Conditional without manufacturer documentation.
- Clinical use should follow the original FDA-cleared labeling and current manufacturer instructions.
Frequently Asked Questions
What are the clinical indications for imax periotips?
Clinical indications are detailed in the FDA documentation, primarily involving portal vein procedures.
What outcomes have been reported in clinical studies?
Studies report on the device's reliability and validity, but specific outcomes related to portal vein interventions are not extensively covered.
What complications have been reported?
Reported complications include general procedural risks, but specific device-related safety data are limited in the evidence.
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.