# K161822: Torcon NB Advantage Catheters

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Oct 27, 2016 after 118 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: 3 generations back to K011664 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter, Cook, Inc. (2015) Summary page 4.

## Indications for use
The Torcon NB® Advantage Catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Source page: https://510kreport.com/device/K161822
Methodology: https://510kreport.com/methodology