# K181042: Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 17, 2018 after 28 days
- Product code: DXK (Echocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902245 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902245: Sonicath (TM) 9F, 12 MHZ, Boston Scientific Corp (1990) Summary page 4.

## Indications for use
The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.

Source page: https://510kreport.com/device/K181042
Methodology: https://510kreport.com/methodology