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K Number
K021481
Device Name
BRESAGEN CATHETER, MODEL CS-3000
Manufacturer
BRESAGEN, INC.
Date Cleared
2002-08-06

(90 days)

Product Code
HCA
Regulation Number
882.4100
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.

Device Description

Bresagen Catheter, Model CS-3000

AI/ML Overview

I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a medical device (Bresagen Catheter) and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. It primarily focuses on the regulatory clearance process and the device's intended use.

§ 882.4100 Ventricular catheter.

(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).