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FDA 510(k)

ANGIOFLUSH II FLUID MANAGEMENT SYSTEM

K-Number: K953825 · 1996-02-26

ApplicantAngioDynamics, Inc.
Decision Date1996-02-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANGIOFLUSH II FLUID MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 1996-02-26 under 510(k) number K953825. 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 ANGIOFLUSH II FLUID MANAGEMENT SYSTEM?

ANGIOFLUSH II FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-26. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K953825.

When did ANGIOFLUSH II FLUID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

ANGIOFLUSH II FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 1996-02-26, under 510(k) number K953825.

Who is the listed applicant for ANGIOFLUSH II FLUID MANAGEMENT SYSTEM?

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

What is the FDA product code for ANGIOFLUSH II FLUID MANAGEMENT SYSTEM?

The FDA product code for ANGIOFLUSH II FLUID MANAGEMENT SYSTEM is FPA.

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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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