K160223 is an FDA 510(k) clearance for the VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter. This device is classified as a Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) (Class II - Special Controls, product code NHC).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 8, 2016, 70 days after receiving the submission on January 29, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4100. Used To Gain Access To The Cavities Of The Brain For Injection Of Material Into Or Removal Of Material From The Brain..
| 510(k) Number | K160223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2016 |
| Decision Date | April 08, 2016 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NHC — Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) |
| Device Class | Class II - 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. |