📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K833433 ↗
Decision Date ?
December 29, 1983
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use for vascular access and catheter-based procedures, consistent with the FDA product classification for percutaneous catheters.
- Use in procedures involving access to venous structures when the catheter is compatible with the planned intervention and labeled configuration.
Clinical Applications
- Catheter-based access to venous structures during interventional procedures.
- Assistance with venous stent placement for venous obstruction when consistent with the device's cleared labeling.
- Use in interventional radiology or vascular surgery procedures requiring percutaneous venous catheter access.
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.
Practical Considerations
- The available FDA record does not specify catheter diameter, working length, tip configuration, guidewire compatibility, or maximum injection pressure; these details should be confirmed in the current product labeling.
- Use requires appropriate imaging guidance, sterile technique, and selection of an access route and catheter size suited to the target vessel and planned procedure.
- MRI safety is not established in the supplied record. Confirm MR Safe, MR Conditional, or MR Unsafe status with the device labeling or manufacturer before MRI.
- Potential contraindications and complications depend on the specific model and procedure and may include bleeding, infection, vessel injury, thrombosis, embolization, and contrast-related complications.
- The FDA clearance date does not confirm that the device remains commercially available or that the original labeling is current.
Procedures that use this device
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.