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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 a medical device manufactured by Nuvera Medical, Inc.. It received FDA 510(k) clearance on 2021-03-05 under approval 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. It is manufactured by Nuvera Medical, Inc.. The 510(k) number is K201775.

When was NuVision ICE Catheter approved by the FDA?

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

What company makes NuVision ICE Catheter?

NuVision ICE Catheter is manufactured by Nuvera Medical, Inc..

What is the FDA product code for NuVision ICE Catheter?

The FDA product code for NuVision ICE Catheter is OBJ.

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Official Source

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