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K Number
K003322
Device Name
CODMAN BACTISEAL CATHETERS
Manufacturer
Codman & Shurtleff, Inc.
Date Cleared
2001-10-01

(342 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
Device Description
AI/ML Overview

§ 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).