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FDA 510(k)

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

K-Number: K200195 · 2020-06-22

ApplicantNortheast Scientific, Inc.
Decision Date2020-06-22
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is a medical device manufactured by Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2020-06-22 under approval number K200195. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter?

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2020-06-22. It is manufactured by Northeast Scientific, Inc.. The 510(k) number is K200195.

When was NES Reprocessed Visions PV .014P RX Digital IVUS Catheter approved by the FDA?

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter received FDA 510(k) clearance on 2020-06-22, under approval number K200195.

What company makes NES Reprocessed Visions PV .014P RX Digital IVUS Catheter?

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is manufactured by Northeast Scientific, Inc..

What is the FDA product code for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter?

The FDA product code for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is OBJ.

Other Devices by Northeast Scientific, Inc.

K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

Related Devices (Code: OBJ)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

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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