# K212224: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform

- Pathway: 510(k) (Special)
- Applicant: Imperative Care, Inc.
- Decided: Sep 20, 2021 after 66 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: 8 generations back to K010954 (2001). 13 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform, Imperative Care, Inc. (2021) Summary page 4.
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length, Imperative Care, Inc. (2018) Summary page 4.

## Most influential descendants
- K231168: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (2023), 2 descendants of its own
- K240948: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (2024), 1 descendant of its own
- K230726: CEREGLIDE 92 Intermediate Catheter (2023), 1 descendant of its own
- K252297: Toro 88 Superbore Catheter (2026), 0 descendants of its own
- K233982: CEREGLIDE 92 Catheter System (2024), 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 is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K212224
Methodology: https://510kreport.com/methodology