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FDA 510(k)

DORA Tubing Sets for Hemodialysis

K-Number: K161582 · 2017-06-16

ApplicantBain Medical Equipment (Guangzhou) Co., Ltd.
Decision Date2017-06-16
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DORA Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K161582. 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 DORA Tubing Sets for Hemodialysis?

DORA Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K161582.

When did DORA Tubing Sets for Hemodialysis receive FDA 510(k) clearance?

DORA Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2017-06-16, under 510(k) number K161582.

Who is the listed applicant for DORA Tubing Sets for Hemodialysis?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bain Medical Equipment (Guangzhou) Co., Ltd. as applicant

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)K240164NovaLine SP-C35 Transducer Protector (956007)K213015DORA Disposable A.V. Fistula Needle SetsK201866NovaLine Tubing Sets for HemodialysisK203524Surgical MasksK163025DORA Disposable A.V. Fistula Needle Sets

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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.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, Inc.

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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