# K113008: Kodama Intravascular Ulrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Silicon Vally Medical Instruments, Inc.
- Decided: Jun 14, 2012 after 251 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boston Scientific Corporation's Atlantis SIR Pro/Pro 2: named in the summary without a submission number

## Most influential descendants
- K173063: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2017), 2 descendants of its own
- K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2019), 1 descendant of its own
- K193183: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (2020), 0 descendants of its own

## Indications for use
Silicon Valley Medical Instrument's Kodama Intravascular Ultrasound Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K113008
Methodology: https://510kreport.com/methodology