Cleared Traditional

Octane aspiration system (K173266) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173266 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
51d
Days
Class 2
Risk

K173266 is an FDA 510(k) clearance for the Octane aspiration system. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 1, 2017 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K173266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2017
Decision Date December 01, 2017
Days to Decision 51 days
Submission Type Traditional
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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K173266.
Aspiron(TM) Aspiration Catheter
K190619 · Meril Life Sciences Private Limited · Apr 2019
JETi 88 Peripheral Thrombectomy System
K183403 · Walk Vascular, LLC · Apr 2019
Octane Mechanical Thrombectomy System
K182232 · Vascular Solutions, Inc. · Sep 2018
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc. · Jun 2012