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FDA 510(k)

EZ SET INFUSION SET

K-Number: K012754 · 2001-08-27

ApplicantAnimas Corp.
Decision Date2001-08-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ SET INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2001-08-27 under 510(k) number K012754. 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 EZ SET INFUSION SET?

EZ SET INFUSION SET is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Animas Corp.. The 510(k) number is K012754.

When did EZ SET INFUSION SET receive FDA 510(k) clearance?

EZ SET INFUSION SET received FDA 510(k) clearance on 2001-08-27, under 510(k) number K012754.

Who is the listed applicant for EZ SET INFUSION SET?

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

What is the FDA product code for EZ SET INFUSION SET?

The FDA product code for EZ SET INFUSION SET is FPA.

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Other records listing Animas Corp. 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.

K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEMK080587EZ MANAGER MAX DIABETES MANAGEMENT SOFTWAREK063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWAREK042873ANIMAS MODEL IR1250 INSULIN INFUSION PUMPK032257MODEL IR 1200 INSULIN PUMPK022394EZMANAGER PLUS

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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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