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FDA 510(k)

CombiSet Hemodialysis Blood Tubing Set

K-Number: K213992 · 2023-05-31

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2023-05-31
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CombiSet Hemodialysis Blood Tubing Set is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2023-05-31 under approval number K213992. 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 CombiSet Hemodialysis Blood Tubing Set?

CombiSet Hemodialysis Blood Tubing Set is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K213992.

When was CombiSet Hemodialysis Blood Tubing Set approved by the FDA?

CombiSet Hemodialysis Blood Tubing Set received FDA 510(k) clearance on 2023-05-31, under approval number K213992.

What company makes CombiSet Hemodialysis Blood Tubing Set?

CombiSet Hemodialysis Blood Tubing Set is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for CombiSet Hemodialysis Blood Tubing Set?

The FDA product code for CombiSet Hemodialysis Blood Tubing Set is FJK.

Related Clinical Trials

NCT04956120 Effect of Citrate Dialysate on Vascular Calcification COMPLETED NCT06032208 An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL RECRUITING NCT06340269 Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF COMPLETED NCT07538310 Laser Acupuncture for Fatigue in Hemodialysis Patients NOT_YET_RECRUITING NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

K1534492008K2 Hemodialysis Machine K160749CRIT-LINE III Blood Chamber II K172238CAREline Airless Hemodialysis Blood Tubing Sets K171652Fresenius Liberty Select Cycler K162716bibag K181108Fresenius Liberty Select Cycler

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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. K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.

Official Source

View on FDA Database →

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

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