The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Blood Administration Sets.
Device ID | K220558 |
510k Number | K220558 |
Device Name: | Blood Administration Sets |
Classification | Set, Blood Transfusion |
Applicant | Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 |
Contact | James L. Vangeisen |
Correspondent | Meaghan Bonn 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 | Yes |
Date Received | 2022-02-28 |
Decision Date | 2022-11-17 |