The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Spectrum Ventricular Catheter.
| Device ID | K011812 |
| 510k Number | K011812 |
| Device Name: | SPECTRUM VENTRICULAR CATHETER |
| Classification | Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | NHC |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2001-06-11 |
| Decision Date | 2001-11-08 |
| Summary: | summary |