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FDA 510(k)

SUBCUTANEOUS NEEDLE INFUSION SET

K-Number: K082818 · 2008-12-23

ApplicantMarcal Medical, Inc.
Decision Date2008-12-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUBCUTANEOUS NEEDLE INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Marcal Medical, Inc.. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K082818. 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 SUBCUTANEOUS NEEDLE INFUSION SET?

SUBCUTANEOUS NEEDLE INFUSION SET is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Marcal Medical, Inc.. The 510(k) number is K082818.

When did SUBCUTANEOUS NEEDLE INFUSION SET receive FDA 510(k) clearance?

SUBCUTANEOUS NEEDLE INFUSION SET received FDA 510(k) clearance on 2008-12-23, under 510(k) number K082818.

Who is the listed applicant for SUBCUTANEOUS NEEDLE INFUSION SET?

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

What is the FDA product code for SUBCUTANEOUS NEEDLE INFUSION SET?

The FDA product code for SUBCUTANEOUS NEEDLE INFUSION SET is FPA.

Related Clinical Trials

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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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