# K231176: Stingray LP Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: May 25, 2023 after 30 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K890505 (1989). 55 ancestors in all.
No later device cites it as a predicate yet.
3 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152401: Stingray LP Catheter, Boston Scientific Corporation (2015) Summary page 4.

## Indications for use
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary vasculature. When used as part of the system consisting of the CrossBoss™ Catheter, Stingray LP Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.

Source page: https://510kreport.com/device/K231176
Methodology: https://510kreport.com/methodology