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FDA 510(k)

INFUSION SET SCALP VEIN

K-Number: K841186 · 1984-05-21

ApplicantMarbex, Inc.
Decision Date1984-05-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION SET SCALP VEIN is the device name listed in this FDA 510(k) record. The listed applicant is Marbex, Inc.. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K841186. 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 INFUSION SET SCALP VEIN?

INFUSION SET SCALP VEIN is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Marbex, Inc.. The 510(k) number is K841186.

When did INFUSION SET SCALP VEIN receive FDA 510(k) clearance?

INFUSION SET SCALP VEIN received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841186.

Who is the listed applicant for INFUSION SET SCALP VEIN?

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

What is the FDA product code for INFUSION SET SCALP VEIN?

The FDA product code for INFUSION SET SCALP VEIN 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 Marbex, Inc. 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.

K841187BLOOD COLLECTION SET, STERILE, DISPOS.K841185PLASTIC, STERILE TUBING CLOSED SETK834368SURGICAL DISPOSABLE STERILE & NONSTERIL

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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