The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Universa Percultaneous Drainage Catheter.
| Device ID | K140085 |
| 510k Number | K140085 |
| Device Name: | UNIVERSA PERCULTANEOUS DRAINAGE CATHETER |
| Classification | Catheter, Malecot |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Elysia Easton |
| Correspondent | Elysia Easton COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | FEW |
| Subsequent Product Code | KOB |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-11-18 |
| Summary: | summary |