The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Aprima Smartesis Centesis Pump.
| Device ID | K161002 |
| 510k Number | K161002 |
| Device Name: | Aprima Smartesis Centesis Pump |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Erum B. Nasir |
| Correspondent | Erum B. Nasir COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-09-28 |
| Summary: | summary |