Cleared Traditional

PCA Syringe Sets

K212262 · Baxter Healthcare Corporation · General Hospital
Oct 2022
Decision
440d
Days
Class 2
Risk

About This 510(k) Submission

K212262 is an FDA 510(k) clearance for the PCA Syringe 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 October 3, 2022, 440 days after receiving the submission on July 20, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K212262 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2021
Decision Date October 03, 2022
Days to Decision 440 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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