# K210601: Plato 17 Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Vascular, LLC
- Decided: Apr 28, 2021 after 58 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960806 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042568: Excelsior 1018 and SL-10 Microcatheters, Boston Scientific Corp (2004) Summary page 4.

## Most influential descendants
- K223560: Plato 17 Microcatheter (2023), 0 descendants of its own

## Recalls of this device
- Feb 1, 2023 · Class II · Z-1249-2023: Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to

## Indications for use
The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.

Source page: https://510kreport.com/device/K210601
Methodology: https://510kreport.com/methodology