Cleared Traditional

Revaclear 500, Revaclear 400, Revaclear 300

K213639 · Baxter Healthcare Corporation · Gastroenterology & Urology
Jan 2022
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K213639 is an FDA 510(k) clearance for the Revaclear 500, Revaclear 400, Revaclear 300, 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 January 24, 2022, 67 days after receiving the submission on November 18, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number K213639 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2021
Decision Date January 24, 2022
Days to Decision 67 days
Submission Type Traditional
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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