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FDA 510(k)

MEDE-FLO I.V. EXTENSION SET

K-Number: K912856 · 1991-12-17

ApplicantMedevice, Inc.
Decision Date1991-12-17
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDE-FLO I.V. EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Medevice, Inc.. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K912856. 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 MEDE-FLO I.V. EXTENSION SET?

MEDE-FLO I.V. EXTENSION SET is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Medevice, Inc.. The 510(k) number is K912856.

When did MEDE-FLO I.V. EXTENSION SET receive FDA 510(k) clearance?

MEDE-FLO I.V. EXTENSION SET received FDA 510(k) clearance on 1991-12-17, under 510(k) number K912856.

Who is the listed applicant for MEDE-FLO I.V. EXTENSION SET?

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

What is the FDA product code for MEDE-FLO I.V. EXTENSION SET?

The FDA product code for MEDE-FLO I.V. EXTENSION SET is FPA.

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Other records listing Medevice, 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.

K072550SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301K920638BIO-MATE PIC CATHETERK901129BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETERK884969BIO-MATE(TM) EPIDURAL CATHETER

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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