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FDA 510(k)

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

K-Number: K232584 · 2023-10-24

ApplicantVein 360, LLC
Decision Date2023-10-24
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is a medical device manufactured by Vein 360, LLC. It received FDA 510(k) clearance on 2023-10-24 under approval number K232584. 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 Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter?

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by Vein 360, LLC. The 510(k) number is K232584.

When was Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter approved by the FDA?

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter received FDA 510(k) clearance on 2023-10-24, under approval number K232584.

What company makes Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter?

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is manufactured by Vein 360, LLC.

What is the FDA product code for Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter?

The FDA product code for Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is OWQ.

Other Devices by Vein 360, LLC

K191073Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter K230928Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter K230584Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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