The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cook Cystostomy Catheter Set.
| Device ID | K181097 |
| 510k Number | K181097 |
| Device Name: | Cook Cystostomy Catheter Set |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | Cook Incorporated 750 Daniels Way, P.0. Box 489 Bloomington, IN 47402 |
| Contact | Danlu Chen |
| Correspondent | Danlu Chen Cook Incorporated 750 Daniels Way, P.0. Box 489 Bloomington, IN 47402 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-26 |
| Decision Date | 2019-01-18 |
| Summary: | summary |