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FDA 510(k)

FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)

K-Number: K852606 · 1985-09-19

ApplicantInfarkem Corp.
Decision Date1985-09-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) is the device name listed in this FDA 510(k) record. The listed applicant is Infarkem Corp.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K852606. 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 FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)?

FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Infarkem Corp.. The 510(k) number is K852606.

When did FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) receive FDA 510(k) clearance?

FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) received FDA 510(k) clearance on 1985-09-19, under 510(k) number K852606.

Who is the listed applicant for FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)?

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 FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)?

The FDA product code for FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) 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.

K851236HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLESK851336IV/0165 INFUSION SET

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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