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FDA 510(k)

SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS

K-Number: K061285 · 2006-07-26

ApplicantCardinal Health, Alaris Products
Decision Date2006-07-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Alaris Products. It received FDA 510(k) clearance on 2006-07-26 under 510(k) number K061285. 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 SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS?

SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS is a medical device that received FDA 510(k) clearance on 2006-07-26. The listed applicant is Cardinal Health, Alaris Products. The 510(k) number is K061285.

When did SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS receive FDA 510(k) clearance?

SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS received FDA 510(k) clearance on 2006-07-26, under 510(k) number K061285.

Who is the listed applicant for SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS?

The FDA 510(k) record lists Cardinal Health, Alaris Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS?

The FDA product code for SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS 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 Cardinal Health, Alaris Products 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.

K071400SMARTSITE STOPCOCKK071108TEXIUM SYRINGEK053049ALARIS SAFETY MALE LUERK052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBDK051641ALARIS SYSTEM PC UNIT, MODEL 8001K050115BLOOD HAND PUMP ADMINISTRATION SET

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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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