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K Number
K003322

Validate with FDA (Live)

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
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K020667,K102589,K110560,K110751,K112156
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).