FDA 510(k)

Dimesol Tubing Sets for Hemodialysis

K-Number: K171952 · 2018-03-30

Decision Date2018-03-30

Product CodeFJK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Dimesol Tubing Sets for Hemodialysis is a medical device manufactured by Dimesol, Inc.. It received FDA 510(k) clearance on 2018-03-30 under approval number K171952. 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 Dimesol Tubing Sets for Hemodialysis?

Dimesol Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Dimesol, Inc.. The 510(k) number is K171952.

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

Dimesol Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2018-03-30, under approval number K171952.

What company makes Dimesol Tubing Sets for Hemodialysis?

Dimesol Tubing Sets for Hemodialysis is manufactured by Dimesol, Inc..

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

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

Other Devices by Dimesol, Inc.

K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

Related Devices (Code: FJK)

K150304Oxyless Blood Tubing SetOxyless, Ltd. K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. K210782Tablo CartridgeOutset Medical, Inc. K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. 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.