Cleared Special

K182232 - Octane Mechanical Thrombectomy System

K182232 is an FDA 510(k) clearance for Octane Mechanical Thrombectomy System, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 25-day FDA review.

K182232 · Vascular Solutions, Inc. · Cardiovascular device
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Sep 2018
Decision
25d
Days
Class 2
Risk

K182232 is an FDA 510(k) clearance for the Octane Mechanical Thrombectomy System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 11, 2018 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K182232

510(k) Number K182232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 85
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K182232.
JETi Peripheral Thrombectomy System
K192439 · Walk Vascular, LLC · Dec 2019
Aspiron(TM) Aspiration Catheter
K190619 · Meril Life Sciences Private Limited · Apr 2019
JETi 88 Peripheral Thrombectomy System
K183403 · Walk Vascular, LLC · Apr 2019
Octane aspiration system
K173266 · Vascular Solutions, Inc. · Dec 2017
ClearLumen II Peripheral Thrombectomy System
K172000 · Walk Vascular, LLC · Oct 2017
ClearLumen II Peripheral Thrombectomy System
K163051 · Walk Vascular, LLC · Feb 2017