đź“‹ FDA Reference
lifepak r invasive pressure adapter cable interfaces with icu medical transpack iv invasive pressure transducers or equivalent 11230-000021 lifepak r invasive pressure adapter cable interfaces with edwards lifesciences truwave invasive pressure transducers or equivalent 11230-000024
Physio-Control
Summary: The LIFEPAK R Invasive Pressure Adapter Cable is used to interface with pressure transducers for monitoring invasive blood pressure. It is primarily used by clinicians in critical care settings.
FDA Clearance Information
Pathway
510K
Number
K240156 ↗
Decision Date
April 30, 2024
Product Code
DSA
Device Class
Class 2
Evidence
0 studies
The LIFEPAK R Invasive Pressure Adapter Cable, manufactured by Physio-Control, was cleared via the FDA 510k pathway on April 30, 2024. It is a Class 2 device under product code DSA.
What It Is
The LIFEPAK R Invasive Pressure Adapter Cable is a medical device designed to connect invasive pressure transducers to monitoring systems. It facilitates the accurate measurement of blood pressure within arteries, providing real-time data crucial for patient management in critical care. This device is compatible with ICU Medical Transpac IV and Edwards Lifesciences TruWave transducers.
Clinical Applications
This adapter cable is commonly used in intensive care units and operating rooms where continuous blood pressure monitoring is essential. It is particularly useful in managing patients undergoing major surgeries, those with unstable hemodynamics, or in critical conditions such as shock or severe trauma. Anesthesiologists, intensivists, and critical care nurses frequently utilize this device.
Indications for Use
The device is indicated for use in patients requiring invasive blood pressure monitoring. This includes individuals in critical care settings who need precise blood pressure management due to conditions like severe trauma, major surgery, or cardiovascular instability.
Practical Considerations
The adapter cable is designed to be compatible with specific pressure transducers, ensuring seamless integration into existing monitoring systems. Clinicians should ensure proper connection and calibration to maintain accuracy. It is important to follow manufacturer guidelines for setup and use.
Frequently Asked Questions
What is the LIFEPAK R Invasive Pressure Adapter Cable used for?
It is used to connect invasive pressure transducers to monitoring systems for accurate blood pressure measurement.
What specialties typically use this device?
This device is typically used by anesthesiologists, intensivists, and critical care nurses in settings like ICUs and operating rooms.
What are the FDA-cleared indications?
The device is cleared for use in patients needing invasive blood pressure monitoring, particularly in critical care scenarios.
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.