Cleared Special

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

K232467 · Baxter Healthcare Corporation · Gastroenterology & Urology
Sep 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K232467 is an FDA 510(k) clearance for the CleanCart A, CleanCart C, AK 98 Hemodialysis Machine, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on September 14, 2023, 30 days after receiving the submission on August 15, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number K232467 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2023
Decision Date September 14, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5860

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