Cleared Traditional

Imperative Care Radial 088 Access System

K220807 · Imperative Care, Inc. · Neurology

May 2022

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K220807 is an FDA 510(k) clearance for the Imperative Care Radial 088 Access System, 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 May 17, 2022, 60 days after receiving the submission on March 18, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K220807 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2022
Decision Date	May 17, 2022
Days to Decision	60 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