Cleared Traditional

K193197 - QuickClear Mechanical Thrombectomy System

K193197 is an FDA 510(k) clearance for QuickClear Mechanical Thrombectomy System, manufactured by Volcano Atheromed, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K193197 · Volcano Atheromed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
152d
Days
Class 2
Risk

K193197 is an FDA 510(k) clearance for the QuickClear Mechanical Thrombectomy System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Volcano Atheromed, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 20, 2020 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Volcano Atheromed, Inc. devices

FDA 510(k) Submission Details - K193197

510(k) Number K193197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2019
Decision Date April 20, 2020
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 69
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K193197.
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · AngioDynamics, Inc. · Jun 2021
JETi AIO Peripheral Thrombectomy System
K201998 · Walk Vascular, LLC · Nov 2020
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
K200871 · Control Medical Technology · May 2020
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