Cleared Special

Octane Mechanical Thrombectomy System

K182232 · Vascular Solutions, Inc. · Cardiovascular

Sep 2018

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K182232 is an FDA 510(k) clearance for the Octane Mechanical Thrombectomy System, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 11, 2018, 25 days after receiving the submission on August 17, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K182232 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2018
Decision Date	September 11, 2018
Days to Decision	25 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.