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FDA 510(k)

CONTRAST CONTROL DEVICE

K-Number: K982123 · 1998-07-21

ApplicantMedex, Inc.
Decision Date1998-07-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONTRAST CONTROL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1998-07-21 under 510(k) number K982123. 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 CONTRAST CONTROL DEVICE?

CONTRAST CONTROL DEVICE is a medical device that received FDA 510(k) clearance on 1998-07-21. The listed applicant is Medex, Inc.. The 510(k) number is K982123.

When did CONTRAST CONTROL DEVICE receive FDA 510(k) clearance?

CONTRAST CONTROL DEVICE received FDA 510(k) clearance on 1998-07-21, under 510(k) number K982123.

Who is the listed applicant for CONTRAST CONTROL DEVICE?

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

What is the FDA product code for CONTRAST CONTROL DEVICE?

The FDA product code for CONTRAST CONTROL DEVICE 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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