# K252297: Toro 88 Superbore Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Toro Neurovascular, Inc.
- Decided: Jan 16, 2026 after 177 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 11 generations back to K010954 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240948: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support, Imperative Care, Inc. (2024) Summary page 5.

## Indications for use
The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K252297
Methodology: https://510kreport.com/methodology