FDA 510(k)

Medtronic Extended infusion set

N.º K: K210544 · 2021-07-16

Fecha de decisión2021-07-16

Código de productoFPA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medtronic Extended infusion set is the device name listed in this FDA 510(k) record. The listed applicant is Unomedical A/S. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K210544. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medtronic Extended infusion set?

Medtronic Extended infusion set is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Unomedical A/S. The 510(k) number is K210544.

When did Medtronic Extended infusion set receive FDA 510(k) clearance?

Medtronic Extended infusion set received FDA 510(k) clearance on 2021-07-16, under 510(k) number K210544.

Who is the listed applicant for Medtronic Extended infusion set?

The FDA 510(k) record lists Unomedical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medtronic Extended infusion set?

The FDA product code for Medtronic Extended infusion set is FPA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Unomedical A/S como solicitante

K192647neria guard Infusion Set K173879MiniMed Mio Advance infusion set K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

Dispositivos relacionados (Código: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe 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 Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

Fuente oficial

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