The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Blood Administration Set.
| Device ID | K210335 |
| 510k Number | K210335 |
| Device Name: | Blood Administration Set |
| Classification | Set, Blood Transfusion |
| Applicant | Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 |
| Contact | James L. Vangeisen |
| Correspondent | James L. Vangeisen Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-05 |
| Decision Date | 2021-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412653308 | K210335 | 000 |