# K222568: OptiCross™ 18 Peripheral Imaging Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Sep 23, 2022 after 30 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: 4 generations back to K970049 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160514: OptiCross 18, 30 MHz Peripheral Imaging Catheter, Boston Scientific Corporation (2016) Summary page 4.

## Indications for use
OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K222568
Methodology: https://510kreport.com/methodology