# K223560: Plato 17 Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Vascular, Inc.
- Decided: Aug 21, 2023 after 266 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 5 generations back to K960806 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210601: Plato 17 Microcatheter, Scientia Vascular, LLC (2021) Summary page 4.

## Recalls of this device
- Jan 16, 2025 · Class II · Z-1235-2025: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

## Indications for use
The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials 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/K223560
Methodology: https://510kreport.com/methodology