Cleared Traditional

SANSIN Tubing Sets for Hemodialysis

K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Gastroenterology & Urology

Sep 2021

Decision

348d

Days

Class 2

Risk

About This 510(k) Submission

K202796 is an FDA 510(k) clearance for the SANSIN Tubing Sets for Hemodialysis, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Jiangxi Sanxin Medtec Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on September 6, 2021, 348 days after receiving the submission on September 23, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K202796 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2020
Decision Date	September 06, 2021
Days to Decision	348 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5820