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FDA 510(k)

STRATO LIFEPORT LARGE BORE INFUSION SET

K-Number: K921576 · 1992-09-21

ApplicantStarto Medical Corp.
Decision Date1992-09-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STRATO LIFEPORT LARGE BORE INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Starto Medical Corp.. It received FDA 510(k) clearance on 1992-09-21 under 510(k) number K921576. 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 STRATO LIFEPORT LARGE BORE INFUSION SET?

STRATO LIFEPORT LARGE BORE INFUSION SET is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is Starto Medical Corp.. The 510(k) number is K921576.

When did STRATO LIFEPORT LARGE BORE INFUSION SET receive FDA 510(k) clearance?

STRATO LIFEPORT LARGE BORE INFUSION SET received FDA 510(k) clearance on 1992-09-21, under 510(k) number K921576.

Who is the listed applicant for STRATO LIFEPORT LARGE BORE INFUSION SET?

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

What is the FDA product code for STRATO LIFEPORT LARGE BORE INFUSION SET?

The FDA product code for STRATO LIFEPORT LARGE BORE 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

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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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