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FDA 510(k)

NIPRO SAFE TOUCH HUBER INFUSION SET

K-Number: K113470 · 2012-10-17

ApplicantNipro Medical Corporation
Decision Date2012-10-17
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIPRO SAFE TOUCH HUBER INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2012-10-17 under 510(k) number K113470. 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 NIPRO SAFE TOUCH HUBER INFUSION SET?

NIPRO SAFE TOUCH HUBER INFUSION SET is a medical device that received FDA 510(k) clearance on 2012-10-17. The listed applicant is Nipro Medical Corporation. The 510(k) number is K113470.

When did NIPRO SAFE TOUCH HUBER INFUSION SET receive FDA 510(k) clearance?

NIPRO SAFE TOUCH HUBER INFUSION SET received FDA 510(k) clearance on 2012-10-17, under 510(k) number K113470.

Who is the listed applicant for NIPRO SAFE TOUCH HUBER INFUSION SET?

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

What is the FDA product code for NIPRO SAFE TOUCH HUBER INFUSION SET?

The FDA product code for NIPRO SAFE TOUCH HUBER INFUSION SET is FPA.

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Other records listing Nipro Medical Corporation as applicant

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K261399ELISIO™-HXK253047PRESSONE™K260533ELISIO™-HK222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleK212677aboNT SYRINGEK190037Cronus HP PTA Balloon Catheter

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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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