Cleared Traditional

Intravascular Administration Sets

K203609 · Baxter Healthcare Corporation · General Hospital
Sep 2021
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K203609 is an FDA 510(k) clearance for the Intravascular Administration Sets, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on September 30, 2021, 294 days after receiving the submission on December 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K203609 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2020
Decision Date September 30, 2021
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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