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FDA 510(k)

Novasight Hybrid System

K-Number: K252945 · 2026-04-17

ApplicantConavi Medical, Inc.
Decision Date2026-04-17
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Novasight Hybrid System is a medical device manufactured by Conavi Medical, Inc.. It received FDA 510(k) clearance on 2026-04-17 under approval number K252945. 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 Novasight Hybrid System?

Novasight Hybrid System is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Conavi Medical, Inc.. The 510(k) number is K252945.

When was Novasight Hybrid System approved by the FDA?

Novasight Hybrid System received FDA 510(k) clearance on 2026-04-17, under approval number K252945.

What company makes Novasight Hybrid System?

Novasight Hybrid System is manufactured by Conavi Medical, Inc..

What is the FDA product code for Novasight Hybrid System?

The FDA product code for Novasight Hybrid System is OBJ.

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Other Devices by Conavi Medical, Inc.

K162789Foresight Intracardiac Echocardiology (ICE) System K172258Novasight Hybrid System

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.

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