Cleared Traditional

DORA Tubing Sets for Hemodialysis

K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Gastroenterology & Urology

Jun 2017

Decision

373d

Days

Class 2

Risk

About This 510(k) Submission

K161582 is an FDA 510(k) clearance for the DORA Tubing Sets for Hemodialysis, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 16, 2017, 373 days after receiving the submission on June 8, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K161582 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2016
Decision Date	June 16, 2017
Days to Decision	373 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