DeviceClearance

Novasight Hybrid System— 510(k) K252945

Substantially Equivalent

Conavi Medical, Inc.

FDA 510(k) clearance K252945 for Novasight Hybrid System, Substantially Equivalent on 2026-04-17. Applicant: Conavi Medical, Inc.. Device class: 2.

Summary

Conavi Medical's Novasight Hybrid System is filed under product code OBJ (Catheter, Ultrasound, Intravascular). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 870.1200. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Conavi Medical filed from Toronto, Canada. The record shows 214 calendar days from receipt to decision (September 15, 2025 to April 17, 2026).

Clearance details

Applicant
Conavi Medical, Inc.
Product code
Product code OBJ
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toronto, CA
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OBJ

product code OBJ
Death
38
Injury
634
Malfunction
3,453
Total
4,125

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.