# K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jan 9, 2015 after 466 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 73 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011664 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122937: Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR (Product Prefix), Cook, Inc. (2012) Summary page 4.
- K882796: Slip-Coat (TM) Catheters, Cook, Inc. (1988) Summary page 4.
- K121694: Imager II Angiographic Catheter, Boston Scientific Corp (2012) Summary page 4.

## Most influential descendants
- K161822: Torcon NB Advantage Catheters (2016), 0 descendants of its own

## Recalls of this device
- Oct 21, 2019 · Class II · Z-0435-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0468-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0453-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0447-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0459-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0443-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0445-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0460-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0472-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0465-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0438-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0463-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0427-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0430-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0448-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0441-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0451-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0467-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0432-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0470-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0457-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0458-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0433-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0462-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0421-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0437-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0466-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0426-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0440-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0444-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0428-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0442-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0434-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0431-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0439-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0449-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0461-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0454-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0446-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0452-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0450-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0424-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0455-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0456-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0464-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0422-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0425-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0436-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0423-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Oct 21, 2019 · Class II · Z-0429-2020: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

## Indications for use
The 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/K133130
Methodology: https://510kreport.com/methodology