# K965229: Imager Torque Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 4, 1997 after 63 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
No predicates in its family tree.
11 later devices descend from it; 2 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K011965: Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 (2001), 10 descendants of its own
- 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

## Indications for use
The Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials.

Source page: https://510kreport.com/device/K965229
Methodology: https://510kreport.com/methodology