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FDA 510(k)

VIVAMED FISTULA NEEDLE

K-Number: K903440 · 1992-04-20

ApplicantS.S. Ent.
Decision Date1992-04-20
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VIVAMED FISTULA NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is S.S. Ent.. It received FDA 510(k) clearance on 1992-04-20 under 510(k) number K903440. 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 VIVAMED FISTULA NEEDLE?

VIVAMED FISTULA NEEDLE is a medical device that received FDA 510(k) clearance on 1992-04-20. The listed applicant is S.S. Ent.. The 510(k) number is K903440.

When did VIVAMED FISTULA NEEDLE receive FDA 510(k) clearance?

VIVAMED FISTULA NEEDLE received FDA 510(k) clearance on 1992-04-20, under 510(k) number K903440.

Who is the listed applicant for VIVAMED FISTULA NEEDLE?

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

What is the FDA product code for VIVAMED FISTULA NEEDLE?

The FDA product code for VIVAMED FISTULA NEEDLE is FIE.

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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

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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