# K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Mar 3, 2021 after 70 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: 7 generations back to K010954 (2001). 12 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K214048: Millipede 088 Access Catheter (2022), 6 descendants of its own
- K212224: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (2021), 6 descendants of its own
- K231802: Millipede 088 Access Catheter (2023), 5 descendants of its own
- K233648: Millipede 088 Access Catheter (2023), 4 descendants of its own
- K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2024), 3 descendants of its own

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

Source page: https://510kreport.com/device/K203764
Methodology: https://510kreport.com/methodology