Devices · Conavi Medical, Inc.

Novasight Hybrid System

Conavi Medical, Inc. is listed for Novasight Hybrid System (K252945). The FDA list gives April 17, 2026 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OBJ as “Catheter, Ultrasound, Intravascular”: For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252945

Official FDA database record

Date of final decision

April 17, 2026

Company on the FDA list

Conavi Medical, Inc.

Lead panel

Cardiovascular

Primary product code

OBJ

openFDA device name for the code

Catheter, Ultrasound, Intravascular

Device class

2

Regulation number

870.1200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary