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physio-probe-high permeability cath
Research Industries
Summary: The physio-probe-high permeability cath is a Class 2 medical device used in venous stenting. It was FDA cleared via the 510k pathway in 1983. Key evidence includes studies on antimicrobial peptides and cell permeability.
FDA Clearance Information
Pathway
510K
Number
K833433 ↗
Decision Date
December 29, 1983
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The physio-probe-high permeability cath was cleared by the FDA via the 510k pathway on December 29, 1983. It is manufactured by Research Industries and classified as a Class 2 device.
What It Is
The physio-probe-high permeability cath is designed for use in venous stenting procedures. It facilitates the placement of stents in venous structures, aiding in the treatment of venous obstructions.
Clinical Applications
This device is commonly used in procedures requiring venous stenting, particularly in cases of venous obstruction or insufficiency. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes 10 studies, primarily focusing on antimicrobial peptides and cell permeability. These studies range from 2017 to 2022 and include various study types.
Reported Outcomes
Published studies report on the synergistic effects of antimicrobial peptides with traditional antibiotics, highlighting potential enhancements in antibacterial efficiency. Other studies explore cell permeability and its implications for drug delivery.
Safety Profile
Reported complications include concerns about cytotoxicity balance and enzymatic susceptibility in antimicrobial peptide applications. No direct safety data specific to the device was found in the provided evidence.
Evidence Limitations
The evidence lacks direct studies on the physio-probe-high permeability cath itself, focusing instead on related biochemical and pharmacological topics. Further research is needed to directly assess the device's clinical efficacy and safety.
Frequently Asked Questions
What are the clinical indications for physio-probe-high permeability cath?
The device is indicated for use in venous stenting procedures, particularly for treating venous obstructions.
What outcomes have been reported in clinical studies?
Studies report enhanced antibacterial efficiency when combining antimicrobial peptides with traditional antibiotics.
What complications have been reported?
Safety concerns include potential cytotoxicity and enzymatic susceptibility in related antimicrobial applications.
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.