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FDA 510(k)

CLEO 90 INFUSION SET

K-Number: K042172 · 2004-10-07

ApplicantSmiths Medical MD, Inc.
Decision Date2004-10-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLEO 90 INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical MD, Inc.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042172. 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 CLEO 90 INFUSION SET?

CLEO 90 INFUSION SET is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Smiths Medical MD, Inc.. The 510(k) number is K042172.

When did CLEO 90 INFUSION SET receive FDA 510(k) clearance?

CLEO 90 INFUSION SET received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042172.

Who is the listed applicant for CLEO 90 INFUSION SET?

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

What is the FDA product code for CLEO 90 INFUSION SET?

The FDA product code for CLEO 90 INFUSION SET is FPA.

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Other records listing Smiths Medical MD, 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.

K112407SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERSK111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)K101180GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,K091181LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPSK082783CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CAREK081156CADD MEDICATION CASSETTE RESERVOIR

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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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