The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Turbo-flo Picc Sets.
| Device ID | K161496 |
| 510k Number | K161496 |
| Device Name: | Turbo-Flo PICC Sets |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-10-07 |
| Summary: | summary |