The following data is part of a premarket notification filed by Hemasure, Inc. with the FDA for Microfilter, Blood Transfusion.
| Device ID | BK980014 |
| 510k Number | BK980014 |
| Device Name: | Microfilter, Blood Transfusion |
| Classification | Microfilter, Blood Transfusion |
| Applicant | Hemasure, Inc. 140 Locke Drive Marlborough, MA 01752 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1999-05-27 |