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FDA 510(k)

BURETTE-IN LINE (150 ML)

K-Number: K023595 · 2002-12-18

ApplicantTuta Healthcare Pty Limited
Decision Date2002-12-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURETTE-IN LINE (150 ML) is the device name listed in this FDA 510(k) record. The listed applicant is Tuta Healthcare Pty Limited. It received FDA 510(k) clearance on 2002-12-18 under 510(k) number K023595. 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 BURETTE-IN LINE (150 ML)?

BURETTE-IN LINE (150 ML) is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Tuta Healthcare Pty Limited. The 510(k) number is K023595.

When did BURETTE-IN LINE (150 ML) receive FDA 510(k) clearance?

BURETTE-IN LINE (150 ML) received FDA 510(k) clearance on 2002-12-18, under 510(k) number K023595.

Who is the listed applicant for BURETTE-IN LINE (150 ML)?

The FDA 510(k) record lists Tuta Healthcare Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURETTE-IN LINE (150 ML)?

The FDA product code for BURETTE-IN LINE (150 ML) 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 Tuta Healthcare Pty Limited 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.

K023039BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015K020083TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

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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