FDA 510(k)

SANSIN Tubing Sets for Hemodialysis

K-Number: K202796 · 2021-09-06

ApplicantJiangxi Sanxin Medtec Co., Ltd.

Decision Date2021-09-06

Product CodeFJK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SANSIN Tubing Sets for Hemodialysis is a medical device manufactured by Jiangxi Sanxin Medtec Co., Ltd.. It received FDA 510(k) clearance on 2021-09-06 under approval number K202796. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANSIN Tubing Sets for Hemodialysis?

SANSIN Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2021-09-06. It is manufactured by Jiangxi Sanxin Medtec Co., Ltd.. The 510(k) number is K202796.

When was SANSIN Tubing Sets for Hemodialysis approved by the FDA?

SANSIN Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2021-09-06, under approval number K202796.

What company makes SANSIN Tubing Sets for Hemodialysis?

SANSIN Tubing Sets for Hemodialysis is manufactured by Jiangxi Sanxin Medtec Co., Ltd..

What is the FDA product code for SANSIN Tubing Sets for Hemodialysis?

The FDA product code for SANSIN Tubing Sets for Hemodialysis is FJK.

Other Devices by Jiangxi Sanxin Medtec Co., Ltd.

K202719Disposable Medical Face Masks

Related Devices (Code: FJK)

K150304Oxyless Blood Tubing SetOxyless, Ltd. K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc. K210782Tablo CartridgeOutset Medical, Inc. K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.