Cleared Traditional

Blood Administration Set

K210335 · Baxter Healthcare Corporation · General Hospital
Jun 2021
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K210335 is an FDA 510(k) clearance for the Blood Administration Set, 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 June 10, 2021, 125 days after receiving the submission on February 5, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K210335 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2021
Decision Date June 10, 2021
Days to Decision 125 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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