# K011965: Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 13, 2001 after 18 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K965229 (1997). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965229: Imager Torque Catheter, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K090270: Backstop Catheter, Model 60-0000-3100 (2009), 4 descendants of its own
- K103349: Backstop Catheter (2011), 3 descendants of its own
- K102527: Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter (2010), 3 descendants of its own
- K110491: Backstop Catheter (2011), 2 descendants of its own
- K180354: UroGen Ureteral Catheter (2018), 1 descendant 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
- Oct 22, 2009 · Not classified · Z-0337-2010: The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agen

## Indications for use
The Microvasive ® 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.

Source page: https://510kreport.com/device/K011965
Methodology: https://510kreport.com/methodology