# K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: Jun 27, 2019 after 57 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: 9 generations back to K934139 (1995). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum, Volcano Corporation (2015) Summary page 4.
- K173063: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System, Acist Medical Systems, Inc. (2017) Summary page 4.

## Most influential descendants
- K193183: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (2020), 0 descendants of its own

## Indications for use
The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

Source page: https://510kreport.com/device/K191175
Methodology: https://510kreport.com/methodology