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FDA 510(k)

Y-TYPE INFUSION SET (2 LEAD)

K-Number: K800358 · 1980-04-16

ApplicantHaemonetics Corp.
Decision Date1980-04-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Y-TYPE INFUSION SET (2 LEAD) is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800358. 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 Y-TYPE INFUSION SET (2 LEAD)?

Y-TYPE INFUSION SET (2 LEAD) is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Haemonetics Corp.. The 510(k) number is K800358.

When did Y-TYPE INFUSION SET (2 LEAD) receive FDA 510(k) clearance?

Y-TYPE INFUSION SET (2 LEAD) received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800358.

Who is the listed applicant for Y-TYPE INFUSION SET (2 LEAD)?

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

What is the FDA product code for Y-TYPE INFUSION SET (2 LEAD)?

The FDA product code for Y-TYPE INFUSION SET (2 LEAD) 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

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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