Cleared Special

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform

K212224 · Imperative Care, Inc. · Neurology

Sep 2021

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K212224 is an FDA 510(k) clearance for the TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on September 20, 2021, 66 days after receiving the submission on July 16, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K212224 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2021
Decision Date	September 20, 2021
Days to Decision	66 days
Submission Type	Special
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