Cleared Traditional

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

K201867 · Baxter Healthcare Corporation · Gastroenterology & Urology
Nov 2020
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K201867 is an FDA 510(k) clearance for the Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System, a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 19, 2020, 135 days after receiving the submission on July 7, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K201867 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2020
Decision Date November 19, 2020
Days to Decision 135 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FKX — System, Peritoneal, Automatic Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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