Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-ABRM

Q: What is the product code of K071640?

The FDA product code is NHC – Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents), a Class II (moderate risk) device regulated under 21 CFR 882.4100.

FDA 510(k) K071640 · Cook, Inc.

Substantially Equivalent

510(k) numberK071640

Submission

Device name: Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-ABRM
Applicant: Cook, Inc.
Bloomington, IN, US
Received: June 15, 2007
Decision date: July 12, 2007
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NHC – Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4100
Specialty: Neurology
Implant: Yes

Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.

Other 510(k)s with product code NHC

510(k)	Device	Applicant	Decision
K160223	VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…NHC · Special	Cook Incorporated	04/08/2016SE
K011812	Spectrum Ventricular CatheterNHC · Traditional	Cook, Inc.	11/08/2001SE

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Questions and answers

When was Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-ABRM cleared by the FDA?

Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-ABRM (K071640) received a 510(k) decision of Substantially Equivalent on July 12, 2007, 27 days after the submission was received.

What is the product code of K071640?

The FDA product code is NHC – Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents), a Class II (moderate risk) device regulated under 21 CFR 882.4100.