# K162448: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 26, 2017 after 267 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882796 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.

## Most influential descendants
- 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 (2017), 0 descendants of its own

## Recalls of this device
- Apr 2, 2026 · Class I · Z-1935-2026: 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

## Indications for use
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. Sizing catheters have marker bands that can be used for anatomical measurements.

Source page: https://510kreport.com/device/K162448
Methodology: https://510kreport.com/methodology