VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter— 510(k) K160223

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K160223 for VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter, Substantially Equivalent on 2016-04-08. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant
Cook Incorporated
Product code
Code NHC
Device class
Class 2
Regulation
21 CFR 882.4100
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bloomington, IN, US
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