# K252945: Novasight Hybrid System

- Pathway: 510(k) (Traditional)
- Applicant: Conavi Medical, Inc.
- Decided: Apr 17, 2026 after 214 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K934139 (1995). 47 ancestors in all.
No later device cites it as a predicate yet.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172258: Novasight Hybrid System, Conavi Medical, Inc. (2018) Summary page 5.

## Indications for use
The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K252945
Methodology: https://510kreport.com/methodology