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FDA 510(k)

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

K-Number: K223026 · 2023-02-03

ApplicantNortheast Scientific, Inc.
Decision Date2023-02-03
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device manufactured by Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2023-02-03 under approval number K223026. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2023-02-03. It is manufactured by Northeast Scientific, Inc.. The 510(k) number is K223026.

When was NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter approved by the FDA?

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter received FDA 510(k) clearance on 2023-02-03, under approval number K223026.

What company makes NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is manufactured by Northeast Scientific, Inc..

What is the FDA product code for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

The FDA product code for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is OWQ.

Other Devices by Northeast Scientific, Inc.

K200195NES Reprocessed Visions PV .014P RX Digital IVUS Catheter K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

Related Devices (Code: OWQ)

K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersSterilmed, Inc. K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc.

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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