📋 FDA Reference
Lifeglobal Micro TIPS
Life Global Group
Summary: LifeGlobal Micro Tips are specialized devices used in portal vein procedures. They are primarily utilized by interventional radiologists and vascular surgeons for precise applications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152581 ↗
Decision Date ?
April 11, 2016
Product Code ?
MQH
Device Class ?
Class 2
Evidence ?
0 studies
The LifeGlobal Micro Tips were cleared through the FDA 510(k) pathway on April 11, 2016. Manufactured by Life Global Group, they are classified as Class 2 under product code MQH.
What It Is
LifeGlobal Micro Tips are precision-engineered tips designed for use in portal vein procedures. These devices facilitate the delivery of therapeutic agents or diagnostic tools within the portal venous system. Their design ensures minimal trauma to vascular structures, making them ideal for delicate interventions.
FDA-Cleared Indications
- Use in procedures involving the portal vein when delivery of a diagnostic or therapeutic material is required.
- Use with compatible vascular access equipment for targeted access within the portal venous system.
Clinical Applications
- Targeted delivery of therapeutic agents during portal venous interventions.
- Delivery of diagnostic materials for evaluation of the portal venous system.
- Use during image-guided portal vein procedures when a small, precise delivery tip is needed.
Practical Considerations
- Available sizes and configurations should be selected according to the access system, target vessel, and patient anatomy.
- Use requires compatible vascular access equipment and sterile handling according to the manufacturer's instructions.
- The available FDA record does not establish MRI safety; review the current labeling before MRI exposure.
- Contraindications, warnings, pressure limits, and reuse or single-use status should be confirmed in the current instructions for use.
- The device should be used by trained clinicians with imaging guidance and appropriate management of portal venous access risks.
Frequently Asked Questions
What is LifeGlobal Micro Tips used for?
LifeGlobal Micro Tips are used in portal vein procedures to deliver therapeutic agents or perform diagnostics.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, such as delivering medications or conducting diagnostic tests.
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.