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FDA 510(k)

Dimesol Tubing Sets for Hemodialysis

K-Number: K171952 · 2018-03-30

ApplicantDimesol, Inc.
Decision Date2018-03-30
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dimesol Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol, Inc.. It received FDA 510(k) clearance on 2018-03-30 under 510(k) 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. The listed applicant is Dimesol, Inc.. The 510(k) number is K171952.

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

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

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

The FDA 510(k) record lists Dimesol, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Dimesol, Inc. 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.

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

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

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

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