510(k) K071640

Device: VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
Applicant: COOK, INC.
510(k) number: K071640
Product code: NHC
Decision: Substantially Equivalent (SESE)
Decision date: 2007-07-12
Date received: 2007-06-15
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: Theodore Heise
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
K160223	VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter	Cook Incorporated	2016-04-08
K011812	SPECTRUM VENTRICULAR CATHETER	Cook, Inc.	2001-11-08

Legacy Summary#

summary

FDA Review#

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