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FDA 510(k)

I.V. PRIMING SET

K-Number: K913333 · 1991-10-23

ApplicantGainor Medical Europe, Ltd.
Decision Date1991-10-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. PRIMING SET is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K913333. 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 I.V. PRIMING SET?

I.V. PRIMING SET is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K913333.

When did I.V. PRIMING SET receive FDA 510(k) clearance?

I.V. PRIMING SET received FDA 510(k) clearance on 1991-10-23, under 510(k) number K913333.

Who is the listed applicant for I.V. PRIMING SET?

The FDA 510(k) record lists Gainor Medical Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. PRIMING SET?

The FDA product code for I.V. PRIMING SET is FPA.

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Other records listing Gainor Medical Europe, Ltd. 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.

K926448I.V. ADMINISTRATION SETK931828CARELET SAFETY LANCETK931827CLEANLET, CLEANLET XL & KIDSK922441SURESEAL BANDAGEK902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLEK902420CATHETER, NASAL, OXYGEN

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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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