Cleared Special

K071640 - VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM

K071640 is an FDA 510(k) clearance for VENTRICLEAR II, manufactured by Cook, Inc.. The device is a Class 2 Neurology device with product code NHC cleared through the Special 510(k) pathway after a 27-day FDA review.

K071640 · Cook, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
27d
Days
Class 2
Risk

K071640 is an FDA 510(k) clearance for the VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM. Classified as Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) (product code NHC), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 12, 2007 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4100 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071640

510(k) Number K071640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2007
Decision Date July 12, 2007
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 149d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

NHC Device Classification - Class 2, Special Controls

Product Code NHC Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4100
Definition Used To Gain Access To The Cavities Of The Brain For Injection Of Material Into Or Removal Of Material From The Brain.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

K071640 · VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
Download PDF FDA Summary Cook, Inc.