Blood Transfusion Microfilters
Microfilter, Blood Transfusion
Fenwal Inc
The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Blood Transfusion Microfilters.
Pre-market Notification Details
| Device ID | BK980041 |
| 510k Number | BK980041 |
| Device Name: | Blood Transfusion Microfilters |
| Classification | Microfilter, Blood Transfusion |
| Applicant | Fenwal Inc three Corporate Drive Lake Zurich, IL 60047 |
| 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 | 1998-11-18 |
| Decision Date | 1999-07-16 |
NIH GUDID Devices
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