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FDA 510(k)

PLASTIC, STERILE TUBING CLOSED SET

K-Number: K841185 · 1984-05-21

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

Device Summary

PLASTIC, STERILE TUBING CLOSED SET 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 K841185. 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 PLASTIC, STERILE TUBING CLOSED SET?

PLASTIC, STERILE TUBING CLOSED SET 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 K841185.

When did PLASTIC, STERILE TUBING CLOSED SET receive FDA 510(k) clearance?

PLASTIC, STERILE TUBING CLOSED SET received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841185.

Who is the listed applicant for PLASTIC, STERILE TUBING CLOSED SET?

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 PLASTIC, STERILE TUBING CLOSED SET?

The FDA product code for PLASTIC, STERILE TUBING CLOSED 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 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.K841186INFUSION SET SCALP VEINK834368SURGICAL 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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