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FDA 510(k)

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

K-Number: K213089 · 2021-11-10

ApplicantIvenix, Inc.
Decision Date2021-11-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Ivenix, Inc.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K213089. 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 Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Ivenix, Inc.. The 510(k) number is K213089.

When did Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector receive FDA 510(k) clearance?

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector received FDA 510(k) clearance on 2021-11-10, under 510(k) number K213089.

Who is the listed applicant for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

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

What is the FDA product code for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector?

The FDA product code for Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector is FPA.

Related Clinical Trials

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NCT01856166PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in NulliparousCOMPLETED

Other records listing Ivenix, 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.

K183311Ivenix Infusion System (IIS)

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.

K261530iiSure 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)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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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