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FDA 510(k)

LIFEGUARD SAFETY INFUSION SET

K-Number: K013871 · 2002-03-29

ApplicantHorizon Medical Products, Inc.
Decision Date2002-03-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFEGUARD SAFETY INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Medical Products, Inc.. It received FDA 510(k) clearance on 2002-03-29 under 510(k) number K013871. 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 LIFEGUARD SAFETY INFUSION SET?

LIFEGUARD SAFETY INFUSION SET is a medical device that received FDA 510(k) clearance on 2002-03-29. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K013871.

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

LIFEGUARD SAFETY INFUSION SET received FDA 510(k) clearance on 2002-03-29, under 510(k) number K013871.

Who is the listed applicant for LIFEGUARD SAFETY INFUSION SET?

The FDA 510(k) record lists Horizon Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEGUARD SAFETY INFUSION SET?

The FDA product code for LIFEGUARD SAFETY INFUSION SET is FPA.

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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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