Cleared Special

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

K212199 · Merit Medical Systems, Inc. · Cardiovascular

Nov 2021

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K212199 is an FDA 510(k) clearance for the ASAP Aspiration Catheter, ASAPLP Aspiration Catheter, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 3, 2021, 112 days after receiving the submission on July 14, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K212199 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.