The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cook Turbo-flo Hd Acute Hemodialysis Catheter Set/tray.
| Device ID | K161504 |
| 510k Number | K161504 |
| Device Name: | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray |
| Classification | Catheter, Hemodialysis, Non-implanted |
| 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 | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2017-01-06 |
| Summary: | summary |