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FDA 510(k)

NuVision ICE Catheter

K-Number: K201775 · 2021-03-05

ApplicantNuvera Medical, Inc.
Decision Date2021-03-05
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NuVision ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nuvera Medical, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K201775. 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 NuVision ICE Catheter?

NuVision ICE Catheter is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Nuvera Medical, Inc.. The 510(k) number is K201775.

When did NuVision ICE Catheter receive FDA 510(k) clearance?

NuVision ICE Catheter received FDA 510(k) clearance on 2021-03-05, under 510(k) number K201775.

Who is the listed applicant for NuVision ICE Catheter?

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

What is the FDA product code for NuVision ICE Catheter?

The FDA product code for NuVision ICE Catheter is OBJ.

Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

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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