# K193183: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

- Pathway: 510(k) (Special)
- Applicant: Acist Medical Systems, Inc.
- Decided: Mar 20, 2020 after 123 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: 10 generations back to K934139 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System, Acist Medical Systems, Inc. (2019) Summary page 4.

## Recalls of this device
- Jan 22, 2021 · Class I · Z-1161-2021: Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potenti

## Indications for use
The ACIST HD1 System is mtended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging 1s indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter 1s intended for use with the ACIST HD: System.

Source page: https://510kreport.com/device/K193183
Methodology: https://510kreport.com/methodology