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FDA 510(k)

EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)

K-Number: K904685 · 1990-11-21

ApplicantExel Intl.
Decision Date1990-11-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) is the device name listed in this FDA 510(k) record. The listed applicant is Exel Intl.. It received FDA 510(k) clearance on 1990-11-21 under 510(k) number K904685. 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 EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)?

EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) is a medical device that received FDA 510(k) clearance on 1990-11-21. The listed applicant is Exel Intl.. The 510(k) number is K904685.

When did EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) receive FDA 510(k) clearance?

EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) received FDA 510(k) clearance on 1990-11-21, under 510(k) number K904685.

Who is the listed applicant for EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)?

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

What is the FDA product code for EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)?

The FDA product code for EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) is FPA.

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Other records listing Exel Intl. 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.

K992290EXEL INJECTION PLUG WITH CAPK963658EXEL AVF SINGLE NEEDLEK963659EXEL I.V. ADMINISTRATION SETK926119EXEL HUBER INFUSION SET ROTATING WINGK903945EXEL A-V FISTULA SETK895770EXEL HUBER INFUSION SET

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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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