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coron pres monitor kit model 80 left kit model 90
Camino Laboratories
Summary: The Coron Pres Monitor Kit, manufactured by Camino Laboratories, is a medical device used for monitoring intracranial pressure. It is primarily used by neurosurgeons and critical care specialists to manage patients with conditions affecting brain pressure.
FDA Clearance Information
Pathway 510K
Number K853072 ↗
Decision Date December 9, 1985
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Coron Pres Monitor Kit was cleared through the FDA 510(k) pathway on December 9, 1985. Manufactured by Camino Laboratories, it is classified as a Class 2 device under product code DYB.
What It Is
The Coron Pres Monitor Kit is a medical device designed to monitor intracranial pressure (ICP) in patients. It consists of a pressure sensor and a monitoring unit that provides real-time data on the pressure within the cranial cavity. This device is crucial for managing patients with traumatic brain injury, hydrocephalus, or other conditions that can lead to elevated ICP.
Clinical Applications
This device is commonly used in neurosurgical and critical care settings to monitor patients who are at risk of increased intracranial pressure. It is particularly useful in the management of patients with traumatic brain injuries, subarachnoid hemorrhages, or brain tumors. The device helps clinicians make informed decisions about interventions to prevent secondary brain injury.
Indications for Use
The FDA indications for this device include monitoring intracranial pressure in patients with conditions that may cause elevated pressure in the brain. This is critical for patients with head trauma, brain hemorrhages, or other neurological conditions.
Practical Considerations
The Coron Pres Monitor Kit typically includes various catheter sizes to accommodate different patient anatomies. It is compatible with standard ICP monitoring systems and requires careful insertion and calibration to ensure accurate readings. Clinicians should be trained in its use to minimize risks and maximize the benefits of monitoring.
Frequently Asked Questions
What is the Coron Pres Monitor Kit used for?
It is used for monitoring intracranial pressure in patients with conditions that may cause elevated brain pressure.
What specialties typically use this device?
Neurosurgeons and critical care specialists typically use this device.
What are the FDA-cleared indications?
The device is indicated for monitoring intracranial pressure in patients with conditions like traumatic brain injury or hydrocephalus.
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.