đź“‹ FDA Reference
Portex Epidural Filter Model 100 386 010 Various Standard and Custom Trays
Smiths Medical Asd
Summary: The Portex Epidural Filter is a medical device used in epidural procedures to prevent particulate contamination. It is primarily used by anesthesiologists and pain management specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083451 ↗
Decision Date ?
March 4, 2009
Product Code ?
BSN
Device Class ?
Class 2
Evidence ?
0 studies
The Portex Epidural Filter, manufactured by Smiths Medical Asd, was cleared by the FDA via the 510k pathway on March 4, 2009. It is classified as a Class 2 device under product code BSN.
What It Is
The Portex Epidural Filter is designed to filter out particulates from fluids administered during epidural procedures. It works by using a fine mesh to trap unwanted particles, ensuring that only clean fluid enters the epidural space. This device is crucial in maintaining sterility and preventing complications during epidural anesthesia.
FDA-Cleared Indications
- Filtering fluids administered during epidural anesthesia or analgesia.
- Reducing particulate contamination in fluids delivered through an epidural catheter.
Clinical Applications
- Use during epidural anesthesia for surgical procedures.
- Use during epidural analgesia for labor and delivery.
- Use in epidural pain-management procedures when filtration of injected fluid is required.
- Use as a component of compatible epidural kits or procedure trays.
Practical Considerations
- Confirm that the filter, connectors and epidural catheter are compatible before use.
- Inspect the package, filter housing and connections for damage or loss of sterility before opening and during setup.
- Use the filter according to the manufacturer's instructions, including any specified priming, flow-direction and pressure limits.
- The record identifies standard and custom tray configurations; exact dimensions, pore size and connector specifications should be verified in the current product labeling.
- MRI safety status is not established by the FDA record provided. Check the current manufacturer labeling before use in or near an MRI environment.
Frequently Asked Questions
What is the Portex Epidural Filter used for?
It is used to filter out particulates from fluids during epidural procedures to ensure sterility and prevent complications.
What specialties typically use this device?
Anesthesiologists and pain management specialists commonly use this device in hospital and surgical settings.
What are the FDA-cleared indications?
It is indicated for use in preventing particulate contamination during epidural anesthesia and analgesia procedures.
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.