Cleared Traditional

Plato 17 Microcatheter

K223560 · Scientia Vascular, Inc. · Neurology

Aug 2023

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K223560 is an FDA 510(k) clearance for the Plato 17 Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Scientia Vascular, Inc. (West Valley City, US). The FDA issued a Cleared decision on August 21, 2023, 266 days after receiving the submission on November 28, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K223560 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2022
Decision Date	August 21, 2023
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures