# K063611: Saline/ Contrast Media Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: May 23, 2007 after 171 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K953034 (1995). 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)
- K013972: H/S Elliptosphere Catheter Set, Model 61-4005, Ackard Laboratories (2001)

## Indications for use
TVUS (SIS) with saline infusion: * persistent abnormal or dysfunctional uterine bleeding * suspected myometrial or intraluminal abnormalities (e.g., fibroids or polyps) * thickened or irregular endometrium * recurrent pregnancy loss * pre- and post-operative assessment of uterine pathology HSG with contrast media: * unexplained infertility * recurrent pregnancy loss

Source page: https://510kreport.com/device/K063611
Methodology: https://510kreport.com/methodology