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
510K
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.
Clinical Applications
This device is commonly used in obstetric anesthesia for labor and delivery, as well as in surgical settings requiring epidural anesthesia for pain control. Anesthesiologists and pain management specialists use it in hospitals and outpatient surgical centers. It is particularly important in procedures where maintaining a sterile field is critical.
Indications for Use
The FDA indications suggest that this device is used to prevent particulate contamination during epidural procedures. It is intended for patients undergoing epidural anesthesia or analgesia, particularly in settings where sterility is paramount.
Practical Considerations
The Portex Epidural Filter is typically compatible with standard epidural kits and can be found in various tray configurations. Clinicians should ensure proper connection to the epidural catheter and verify the integrity of the filter before use.
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.