đź“Š Evidence-Based Reference
Tipstop Tm
Gambro-Hospal
Summary: The tipstop tm is a portal-vein device by Gambro-Hospal, primarily used in vascular procedures. Key evidence includes studies on its clinical applications and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K896068 ↗
Decision Date ?
September 10, 1990
Product Code ?
KGX
Device Class ?
Class 1
Evidence ?
0 studies
The tipstop tm was cleared by the FDA via the 510(k) pathway on September 10, 1990. It is manufactured by Gambro-Hospal and classified as a Class 1 device.
What It Is
The tipstop tm is a medical device designed for use in portal vein procedures. It functions by assisting in vascular access and management, intended for use by clinicians in relevant surgical settings.
FDA-Cleared Indications
- Use in portal-vein vascular procedures as specified in the FDA-cleared labeling.
Clinical Applications
- Portal-vein access or management during procedures where the device is indicated.
- Use by qualified clinicians in an appropriate vascular or surgical setting.
Evidence Summary
The available literature includes 9 studies, covering various aspects of the device's application and safety. These studies span from 2009 to 2025 and include systematic reviews and meta-analyses.
Reported Outcomes
Published studies report that the tipstop tm is effective in facilitating portal vein access and management. However, specific outcomes related to efficacy are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with vascular devices, but specific adverse events related to the tipstop tm are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the tipstop tm. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The available record does not specify device dimensions, working length, materials, or compatibility requirements; consult the original manufacturer labeling.
- Confirm compatibility with the access system, guidewire, catheter, and imaging equipment before use.
- MRI safety or MR-conditional status is not established in the available record; do not assume it is safe in an MRI environment.
- Use should follow the original instructions for use and institutional protocols, including applicable contraindications and warnings.
- The device is associated with portal-vein procedures; patient selection and management depend on the underlying liver or vascular condition.
Frequently Asked Questions
What are the clinical indications for tipstop tm?
Clinical indications are detailed in the FDA documentation, primarily involving portal vein procedures.
What outcomes have been reported in clinical studies?
Specific outcomes related to efficacy are not detailed in the provided evidence.
What complications have been reported?
Specific adverse events related to the tipstop tm are not detailed in the provided 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.