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FDA 510(k)

RENAX A.V. FISTULA NEEDLE SETS

K-Number: K003123 · 2001-05-04

ApplicantSunder Biomedical Tech. Co., Ltd.
Decision Date2001-05-04
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAX A.V. FISTULA NEEDLE SETS 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 2001-05-04 under 510(k) number K003123. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAX A.V. FISTULA NEEDLE SETS?

RENAX A.V. FISTULA NEEDLE SETS is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Sunder Biomedical Tech. Co., Ltd.. The 510(k) number is K003123.

When did RENAX A.V. FISTULA NEEDLE SETS receive FDA 510(k) clearance?

RENAX A.V. FISTULA NEEDLE SETS received FDA 510(k) clearance on 2001-05-04, under 510(k) number K003123.

Who is the listed applicant for RENAX A.V. FISTULA NEEDLE SETS?

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 A.V. FISTULA NEEDLE SETS?

The FDA product code for RENAX A.V. FISTULA NEEDLE SETS is FIE.

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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-3L70F30JK014140RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

Related Devices (Code: FIE)

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.

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.

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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