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FDA 510(k)

NUVISION™ NAV Ultrasound Catheter

K-Number: K223766 · 2023-02-16

Decision Date2023-02-16
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NUVISION™ NAV Ultrasound Catheter is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-02-16 under approval number K223766. 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™ NAV Ultrasound Catheter?

NUVISION™ NAV Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K223766.

When was NUVISION™ NAV Ultrasound Catheter approved by the FDA?

NUVISION™ NAV Ultrasound Catheter received FDA 510(k) clearance on 2023-02-16, under approval number K223766.

What company makes NUVISION™ NAV Ultrasound Catheter?

NUVISION™ NAV Ultrasound Catheter is manufactured by Biosense Webster, Inc..

What is the FDA product code for NUVISION™ NAV Ultrasound Catheter?

The FDA product code for NUVISION™ NAV Ultrasound Catheter is OBJ.

Related Clinical Trials

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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.