Atlas FDA

NHC

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4100
Medical specialty
Neurology
Flags
Implant
FDA definition
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
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RecordFirmDate
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (K160223)Cook Incorporated2016-04-08
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM (K071640)Cook, Inc.2007-07-12
SPECTRUM VENTRICULAR CATHETER (K011812)Cook, Inc.2001-11-08

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Every clearance here is in the API, with alerts when new ones post.