Cleared Traditional

QuickClear Mechanical Thrombectomy System (K193197) - FDA 510(k) Clearance

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

K193197 · Volcano Atheromed, Inc. · Cardiovascular device
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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

Submission Details

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.

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 34
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