Cleared Traditional

Blood Administration Sets

K220558 · Baxter Healthcare Corporation · General Hospital
Nov 2022
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K220558 is an FDA 510(k) clearance for the Blood Administration Sets, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 17, 2022, 262 days after receiving the submission on February 28, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K220558 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2022
Decision Date November 17, 2022
Days to Decision 262 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code BRZ — Set, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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