# K041818: Sonicath Ultra Imaging Catheter 3.2F 20MHZ, Models 37410/456221/C1020

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 10, 2004 after 127 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sonicath UltraTM Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K041818
Methodology: https://510kreport.com/methodology