The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Ventriclear Ventricular Drainage Catheter Set With Cook Spectrum Antibiotic Impregnation, Ventriclear Ii Ventricular Drainage Catheter.
| Device ID | K160223 |
| 510k Number | K160223 |
| Device Name: | VentriClear Ventricular Drainage Catheter Set With Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter |
| Classification | Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Steven Lawrie |
| Correspondent | Steven Lawrie COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | NHC |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-01-29 |
| Decision Date | 2016-04-08 |
| Summary: | summary |