Cleared Special

K200871 - Aspire MAX 7 - 11F Mechanical Thrombect...

K200871 is the FDA 510(k) clearance for Aspire MAX 7 - 11F Mechanical Thrombect... by Control Medical Technology. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Special 510(k) pathway after a 33-day FDA review.

K200871 · Control Medical Technology · Cardiovascular device
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May 2020
Decision
33d
Days
Class 2
Risk

K200871 is an FDA 510(k) clearance for the Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspir.... Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Control Medical Technology (Salt Lake City, US). The FDA issued a Cleared decision on May 4, 2020 after a review of 33 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 Control Medical Technology devices

Submission Details

510(k) Number K200871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date May 04, 2020
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 50
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K200871.
Thrombuster II Aspiration Catheter
K213166 · Kaneka Medical America, LLC · Oct 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · AngioDynamics, Inc. · Jun 2021
JETi AIO Peripheral Thrombectomy System
K201998 · Walk Vascular, LLC · Nov 2020
QuickClear Mechanical Thrombectomy System
K193197 · Volcano Atheromed, Inc. · Apr 2020
JETi Peripheral Thrombectomy System
K192439 · Walk Vascular, LLC · Dec 2019
Aspiron(TM) Aspiration Catheter
K190619 · Meril Life Sciences Private Limited · Apr 2019