# K172258: Novasight Hybrid System

- Pathway: 510(k) (Traditional)
- Applicant: Conavi Medical, Inc.
- Decided: Apr 27, 2018 after 275 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K934139 (1995). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050995: Revolution 45 MHZ Rotational Ivus Imaging Catheter, Volcano Corporation (2005) Summary page 4.
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter, Lightlab Imaging, Inc. (2014) Summary page 4.
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System, Volcano Corporation (2008) Summary page 4.

## Most influential descendants
- K252945: Novasight Hybrid System (2026), 0 descendants of its own

## Recalls of this device
- Mar 12, 2025 · Class I · Z-1585-2025: Due to manufacturing issues there is a potential for the catheter sheath to detach.

## 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/K172258
Methodology: https://510kreport.com/methodology