The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Transfer Sets.
| Device ID | BK950024 |
| 510k Number | BK950024 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | COBE Cardiovascular, Inc. 1201 Oak Street Lakewood, CO 80215 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-13 |
| Decision Date | 1995-11-29 |