Cleared Traditional

lntravascular Administration Sets with Stopcock and Manifold

K223175 · Baxter Healthcare Corporation · General Hospital
Mar 2023
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K223175 is an FDA 510(k) clearance for the lntravascular Administration Sets with Stopcock and Manifold, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on March 10, 2023, 150 days after receiving the submission on October 11, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K223175 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2022
Decision Date March 10, 2023
Days to Decision 150 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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