FDA 510(k)

NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter

K-Number: K241540 · 2024-06-28

Decision Date2024-06-28

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2024-06-28 under approval number K241540. 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 Ultrasound Catheter; NUVISION NAV Ultrasound Catheter?

NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2024-06-28. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K241540.

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

NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter received FDA 510(k) clearance on 2024-06-28, under approval number K241540.

What company makes NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter?

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

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

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

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Related Devices (Code: OBJ)

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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.