# K123818: Ursa Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: Curative Medical Technology, Inc.
- Decided: Mar 4, 2013 after 82 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921310 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090427: Ursa Angiographic Catheter, Curative Medical Technology, Inc. (2010) Summary page 1.

## Indications for use
The UrsaTM angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.

Source page: https://510kreport.com/device/K123818
Methodology: https://510kreport.com/methodology