# K173289: Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Nov 15, 2017 after 30 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K882796 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
3 of 4 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 5.
- K162448: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter, Cook Incorporated (2017) Summary page 5.

## Recalls of this device
- Apr 2, 2026 · Class I · Z-1936-2026: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and ve
- May 15, 2025 · Class I · Z-1902-2025: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

## Indications for use
The Beacon Tip Catheters are intended for use 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. The Beacon Tip Sizing Catheters are intended for use 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. Beacon Tip Sizing Catheters have marker bands that can be used for anatomical measurements.

Source page: https://510kreport.com/device/K173289
Methodology: https://510kreport.com/methodology