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FDA 510(k)

IVY DEVICES INC. IV/MEDICAL LINE STABILIZER

K-Number: K033208 · 2004-03-18

ApplicantIvy Devices, Inc.
Decision Date2004-03-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVY DEVICES INC. IV/MEDICAL LINE STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Devices, Inc.. It received FDA 510(k) clearance on 2004-03-18 under 510(k) number K033208. 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 IVY DEVICES INC. IV/MEDICAL LINE STABILIZER?

IVY DEVICES INC. IV/MEDICAL LINE STABILIZER is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Ivy Devices, Inc.. The 510(k) number is K033208.

When did IVY DEVICES INC. IV/MEDICAL LINE STABILIZER receive FDA 510(k) clearance?

IVY DEVICES INC. IV/MEDICAL LINE STABILIZER received FDA 510(k) clearance on 2004-03-18, under 510(k) number K033208.

Who is the listed applicant for IVY DEVICES INC. IV/MEDICAL LINE STABILIZER?

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

What is the FDA product code for IVY DEVICES INC. IV/MEDICAL LINE STABILIZER?

The FDA product code for IVY DEVICES INC. IV/MEDICAL LINE STABILIZER 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

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