Cleared Traditional

Intravascular Extension Sets and Accessories

K242339 · Baxter Healthcare Corporation · General Hospital
Feb 2025
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K242339 is an FDA 510(k) clearance for the Intravascular Extension Sets and Accessories, 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 February 28, 2025, 205 days after receiving the submission on August 7, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K242339 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2024
Decision Date February 28, 2025
Days to Decision 205 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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