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FDA 510(k)

HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y

K-Number: K981683 · 1998-07-28

ApplicantVenusa , Ltd.
Decision Date1998-07-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y is the device name listed in this FDA 510(k) record. The listed applicant is Venusa , Ltd.. It received FDA 510(k) clearance on 1998-07-28 under 510(k) number K981683. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y?

HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y is a medical device that received FDA 510(k) clearance on 1998-07-28. The listed applicant is Venusa , Ltd.. The 510(k) number is K981683.

When did HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y receive FDA 510(k) clearance?

HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y received FDA 510(k) clearance on 1998-07-28, under 510(k) number K981683.

Who is the listed applicant for HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y?

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

What is the FDA product code for HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y?

The FDA product code for HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y is FPA.

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Other records listing Venusa , 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.

K994429VENUSA, LTD. EXTENSION SET WITH FILTERK905518BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SETK851975ENTERAL FEEDING BAG, 1000 ML, & TUBING SETK843692FLU VEN I.V. SET 0153-C PERMA-SETK842088FLU MET 2K812981FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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