📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during embolization procedures performed through a catheter.
- Use when controlled delivery of embolic material through a catheter system is required.
Clinical Applications
- Controlled delivery of embolic agents during vascular embolization.
- Catheter-based embolization of selected abnormal or bleeding blood vessels.
- Use as a side-flow fitting with compatible catheter systems during interventional radiology procedures.
Practical Considerations
- Confirm compatibility with the catheter, tubing, connector, and embolic material before use.
- Select components appropriate for the catheter system and the intended flow requirements; the available record does not specify device dimensions or size ranges.
- Use sterile technique and follow the current manufacturer instructions for priming, connection, flushing, and handling.
- The available FDA record does not establish MRI safety; obtain the current labeling or manufacturer guidance before MRI exposure.
- Contraindications, warnings, pressure limits, and embolic-agent compatibility should be checked in the current instructions for use.
Procedures that use this device
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.