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FDA 510(k)

RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

K-Number: K014140 · 2002-11-18

ApplicantSunder Biomedical Tech. Co., Ltd.
Decision Date2002-11-18
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Sunder Biomedical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2002-11-18 under 510(k) number K014140. 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 RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET?

RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET is a medical device that received FDA 510(k) clearance on 2002-11-18. The listed applicant is Sunder Biomedical Tech. Co., Ltd.. The 510(k) number is K014140.

When did RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET receive FDA 510(k) clearance?

RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET received FDA 510(k) clearance on 2002-11-18, under 510(k) number K014140.

Who is the listed applicant for RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET?

The FDA 510(k) record lists Sunder Biomedical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET?

The FDA product code for RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET is FJK.

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Other records listing Sunder Biomedical Tech. 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.

K024007SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30JK003123RENAX A.V. FISTULA NEEDLE SETS

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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