đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Monitoring intracranial pressure in patients with conditions that may cause increased pressure inside the skull.
Clinical Applications
- Monitoring intracranial pressure after severe head trauma.
- Monitoring patients with intracranial hemorrhage or other neurologic conditions associated with increased brain pressure.
- Providing pressure measurements to support management decisions in neurosurgical and critical care settings.
Practical Considerations
- Placement and calibration require trained clinical personnel and sterile technique.
- The kit may include components or catheter sizes selected according to the patient’s anatomy and the monitoring approach.
- Compatibility with the specific pressure monitor and connecting equipment should be confirmed before use.
- The FDA record provided does not establish MRI safety; MRI compatibility should be verified in the manufacturer’s labeling before scanning.
- Potential risks include infection, bleeding, tissue injury, inaccurate readings, and device malfunction. Contraindications and warnings should be reviewed in the current instructions for use.
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.