510(k) K160223

Device: VentriClear Ventricular Drainage Catheter Set With Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
Applicant: COOK INCORPORATED
510(k) number: K160223
Product code: NHC
Decision: Substantially Equivalent (SESE)
Decision date: 2016-04-08
Date received: 2016-01-29
Regulation: 882.4100
Classification name: Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: STEVEN LAWRIE
Address: 750 Daniels Way Bloomington IN US 47404 47404

FDA Registration Numbers#

1820334
3030447506
3030714660

Source Documents#

Other 510(k) Records For Product Code NHC #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K071640	VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM	Cook, Inc.	2007-07-12
K011812	SPECTRUM VENTRICULAR CATHETER	Cook, Inc.	2001-11-08

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases