Cleared Special

K212199 - ASAP Aspiration Catheter

K212199 is the FDA 510(k) clearance for ASAP Aspiration Catheter by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Special 510(k) pathway after a 112-day FDA review.

K212199 · Merit Medical Systems, Inc. · Cardiovascular device
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Nov 2021
Decision
112d
Days
Class 2
Risk

K212199 is an FDA 510(k) clearance for the ASAP Aspiration Catheter, ASAPLP Aspiration Catheter. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 3, 2021 after a review of 112 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K212199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2021
Decision Date November 03, 2021
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 69
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K212199.
JETi™Hydrodynamic Thrombectomy System
K232458 · Abbott Medical · Dec 2023
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
K213388 · AngioDynamics, Inc. · Apr 2022
JETi AIO Peripheral Thrombectomy System
K213565 · Walk Vascular, LLC · Feb 2022
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