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FDA 510(k)

SAFESTEP MAX POWER-INJECTABLE INFUSION SET

K-Number: K073050 · 2008-01-25

ApplicantSpecialized Health Products International, Inc.
Decision Date2008-01-25
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFESTEP MAX POWER-INJECTABLE INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Specialized Health Products International, Inc.. It received FDA 510(k) clearance on 2008-01-25 under 510(k) number K073050. 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 SAFESTEP MAX POWER-INJECTABLE INFUSION SET?

SAFESTEP MAX POWER-INJECTABLE INFUSION SET is a medical device that received FDA 510(k) clearance on 2008-01-25. The listed applicant is Specialized Health Products International, Inc.. The 510(k) number is K073050.

When did SAFESTEP MAX POWER-INJECTABLE INFUSION SET receive FDA 510(k) clearance?

SAFESTEP MAX POWER-INJECTABLE INFUSION SET received FDA 510(k) clearance on 2008-01-25, under 510(k) number K073050.

Who is the listed applicant for SAFESTEP MAX POWER-INJECTABLE INFUSION SET?

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

What is the FDA product code for SAFESTEP MAX POWER-INJECTABLE INFUSION SET?

The FDA product code for SAFESTEP MAX POWER-INJECTABLE INFUSION SET is FPA.

Related Clinical Trials

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.

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Other records listing Specialized Health Products International, Inc. 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.

K070449LUMILOC (TM) SAFETY INTRODUCER NEEDLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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