The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Transfer Sets.
| Device ID | BK160108 |
| 510k Number | BK160108 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 US |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2016-11-23 |