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phenom 27 catheter
Cathera
Summary: The Phenom 27 Catheter by Cathera is a Class 2 device cleared by the FDA for use in venous stenting. It is supported by two studies, highlighting its application in complex neurointerventions.
FDA Clearance Information
Pathway
510K
Number
K180959 ↗
Decision Date
June 11, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Phenom 27 Catheter received FDA clearance through the 510(k) pathway on June 11, 2018. It is manufactured by Cathera and classified as a Class 2 medical device.
What It Is
The Phenom 27 Catheter is a distal access catheter designed for use in neurointerventional procedures, particularly in the placement of flow diverters for cerebral aneurysms. It facilitates access to complex vascular anatomies.
Clinical Applications
Commonly used in neurointerventions, the Phenom 27 Catheter is employed in procedures requiring precise navigation through intricate cerebral vasculature, such as the treatment of intracranial aneurysms.
Evidence Summary
The available literature includes two studies: a case report from 2025 and a case series from 2021. These studies explore the catheter's use in neurointerventional procedures, particularly focusing on its application in flow diversion.
Reported Outcomes
Published studies report successful use of the Phenom 27 Catheter in complex neurointerventions, such as flow diverter placement for cerebral aneurysms. The case series highlights advantages like reduced procedure time and fewer access-site complications when using transradial access.
Safety Profile
Reported complications include potential challenges in navigating complex vascular anatomy. However, specific adverse events or complications were not detailed in the provided studies.
Evidence Limitations
The evidence is limited to a case report and a case series, which may not provide comprehensive data on long-term outcomes or rare complications. Further research is needed to establish broader safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for Phenom 27 Catheter?
The Phenom 27 Catheter is indicated for use in neurointerventional procedures, particularly for the placement of flow diverters in cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies report successful navigation and placement of flow diverters with reduced procedure time and fewer access-site complications using the Phenom 27 Catheter.
What complications have been reported?
Reported complications include challenges in navigating complex vascular anatomy, though specific adverse events were not detailed in the studies.
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.