The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Ventriclear Ii, Spectrum Ventricular Drainage Catheter, Model N-vvdc-02-abrm.
| Device ID | K071640 |
| 510k Number | K071640 |
| Device Name: | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM |
| Classification | Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) |
| Applicant | COOK, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Theodore Heise |
| Correspondent | Theodore Heise COOK, INC. 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 | 2007-06-15 |
| Decision Date | 2007-07-12 |
| Summary: | summary |