# K102527: Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Nov 5, 2010 after 64 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K965229 (1997). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011965: Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1, Boston Scientific Corp (2001)

## Most influential descendants
- K171600: Renal Access Cobra Catheter, Kumpe Access Catheter (2018), 1 descendant of its own
- K181144: Angled Tip Ureteral Catheter (2018), 0 descendants of its own
- K180530: Imager II Urology Torque Catheter (2018), 0 descendants of its own

## Recalls of this device
- Mar 15, 2012 · Not classified · Z-1393-2012: Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found t

## 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 II 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/K102527
Methodology: https://510kreport.com/methodology