# K200733: Opticross 35 15 MHz Peripheral Imaging Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Apr 17, 2020 after 28 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050684 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080272: Atlantis Pvimaging Catheter, Model H749364560, Boston Scientific Corp (2008) Summary page 4.

## Recalls of this device
- Aug 24, 2020 · Class II · Z-0181-2021: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated.

## Indications for use
The OptiCross 35 15 MHz Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K200733
Methodology: https://510kreport.com/methodology