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FDA 510(k)

IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080

K-Number: K882302 · 1988-07-12

ApplicantY
Decision Date1988-07-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K882302. 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 IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080?

IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Y. The 510(k) number is K882302.

When did IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 receive FDA 510(k) clearance?

IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 received FDA 510(k) clearance on 1988-07-12, under 510(k) number K882302.

Who is the listed applicant for IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080?

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

What is the FDA product code for IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080?

The FDA product code for IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 is FPA.

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Other records listing Y 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.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION 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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