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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 the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2023-05-31 under 510(k) 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. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K213992.

When did CombiSet Hemodialysis Blood Tubing Set receive FDA 510(k) clearance?

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

Who is the listed applicant for CombiSet Hemodialysis Blood Tubing Set?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: FJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K210782Tablo CartridgeOutset Medical, Inc.K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec 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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