DIAMOND II VALVE

• K Number: K991429
• Device Name: DIAMOND II VALVE
• Manufacturer: PHOENIX BIOMEDICAL CORP.
• Date Cleared: 1999-05-19 ( 23 days)
• Product Code: JXG
• Regulation Number: 882.5550
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

This device is intended as the principle pressure regulating component of a CSF shunt assembly, used regulabing compt of hydrocephalus.

Device Description

Not Found

AI/ML Overview

I am sorry but this document does not contain the answer to your question. The document is a 510(k) premarket notification letter from the FDA regarding the "Diamond II Valve" and does not include details about acceptance criteria, device performance studies, or related information.

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).