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FDA 510(k)

IV/0165 INFUSION SET

K-Number: K851336 · 1985-05-30

ApplicantInfarkem Corp.
Decision Date1985-05-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV/0165 INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Infarkem Corp.. It received FDA 510(k) clearance on 1985-05-30 under 510(k) number K851336. 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 IV/0165 INFUSION SET?

IV/0165 INFUSION SET is a medical device that received FDA 510(k) clearance on 1985-05-30. The listed applicant is Infarkem Corp.. The 510(k) number is K851336.

When did IV/0165 INFUSION SET receive FDA 510(k) clearance?

IV/0165 INFUSION SET received FDA 510(k) clearance on 1985-05-30, under 510(k) number K851336.

Who is the listed applicant for IV/0165 INFUSION SET?

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

What is the FDA product code for IV/0165 INFUSION SET?

The FDA product code for IV/0165 INFUSION SET is FPA.

Related Clinical Trials

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.

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Other records listing Infarkem Corp. 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.

K852606FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)K851236HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES

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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