# K231168: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support

- Pathway: 510(k) (Special)
- Applicant: Imperative Care, Inc.
- Decided: May 22, 2023 after 27 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: 9 generations back to K010954 (2001). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212224: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform, Imperative Care, Inc. (2021) Summary page 4.

## Most influential descendants
- K240948: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (2024), 1 descendant of its own
- K252297: Toro 88 Superbore Catheter (2026), 0 descendants of its own

## Indications for use
The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K231168
Methodology: https://510kreport.com/methodology