# K180530: Imager II Urology Torque Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Apr 10, 2018 after 41 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965229 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102527: Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter, Boston Scientific Corporation (2010) Summary page 4.

## Indications for use
The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager Il Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.

Source page: https://510kreport.com/device/K180530
Methodology: https://510kreport.com/methodology