FDA 510(k)

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

Número K: K250592 · 2025-05-12

Data da decisão2025-05-12

Código do produtoOWQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250592. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)?

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is Northeast Scientific, Inc.. The 510(k) number is K250592.

When did NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) receive FDA 510(k) clearance?

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) received FDA 510(k) clearance on 2025-05-12, under 510(k) number K250592.

Who is the listed applicant for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)?

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

What is the FDA product code for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)?

The FDA product code for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is OWQ.

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Outros registros que listam Northeast Scientific, Inc. como candidato(a)

K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter K200195NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Dispositivos Relacionados (Código: OWQ)

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