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FDA 510(k)

MICROFLO-SAFE SCALP VEIN SET

K-Number: K043328 · 2005-04-15

ApplicantDks Loversan Industria Biomedica Spa
Decision Date2005-04-15
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROFLO-SAFE SCALP VEIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Dks Loversan Industria Biomedica Spa. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K043328. 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 MICROFLO-SAFE SCALP VEIN SET?

MICROFLO-SAFE SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is Dks Loversan Industria Biomedica Spa. The 510(k) number is K043328.

When did MICROFLO-SAFE SCALP VEIN SET receive FDA 510(k) clearance?

MICROFLO-SAFE SCALP VEIN SET received FDA 510(k) clearance on 2005-04-15, under 510(k) number K043328.

Who is the listed applicant for MICROFLO-SAFE SCALP VEIN SET?

The FDA 510(k) record lists Dks Loversan Industria Biomedica Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROFLO-SAFE SCALP VEIN SET?

The FDA product code for MICROFLO-SAFE SCALP VEIN SET 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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