Cleared Traditional

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504

K233159 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology
Dec 2023
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K233159 is an FDA 510(k) clearance for the pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on December 1, 2023, 65 days after receiving the submission on September 27, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K233159 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date December 01, 2023
Days to Decision 65 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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