Cleared Special

K212199 - ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

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

K212199 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K212199

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.

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 95
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
K212199 · ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Download PDF FDA Summary Merit Medical Systems…