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pci w cath-seal side flow fitting
Universal Medical Instrument
Summary: The PCI w Cath-Seal Side Flow Fitting is a medical device used in interventional radiology for embolization procedures. It is primarily utilized by interventional radiologists to manage vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K842259 ↗
Decision Date
August 1, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PCI w Cath-Seal Side Flow Fitting was cleared through the FDA 510(k) pathway on August 1, 1984. Manufactured by Universal Medical Instrument, it is classified as a Class 2 device under product code DYB.
What It Is
The PCI w Cath-Seal Side Flow Fitting is a specialized device used in catheter-based procedures. It features a side flow fitting that allows for controlled delivery of embolization materials. This device is essential for procedures that require precise control over the flow of embolic agents to target specific vascular areas.
Clinical Applications
This device is commonly used in interventional radiology for embolization procedures, such as treating aneurysms or arteriovenous malformations. It is particularly useful in settings where precise control of embolic material is necessary, such as in neurointerventional procedures or peripheral vascular interventions. The device is typically used in hospital settings by interventional radiologists.
Indications for Use
The FDA indications suggest this device is intended for use in embolization procedures, which involve blocking blood flow to certain areas. It is suitable for patients with conditions like aneurysms or abnormal blood vessel formations.
Practical Considerations
The PCI w Cath-Seal Side Flow Fitting is compatible with standard catheter systems. Clinicians should ensure proper sizing to match the catheter and embolic material being used. Familiarity with the device's flow control features is essential for optimal performance.
Frequently Asked Questions
What is PCI w Cath-Seal Side Flow Fitting used for?
It is used for embolization procedures to control blood flow in targeted vascular areas.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to treat conditions like aneurysms and arteriovenous malformations.
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.