Cleared Traditional

K213388 - AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

K213388 is an FDA 510(k) clearance for AlphaVac Multipurpose Mechanical Aspira..., manufactured by AngioDynamics, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K213388 · AngioDynamics, Inc. · Cardiovascular device
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Apr 2022
Decision
172d
Days
Class 2
Risk

K213388 is an FDA 510(k) clearance for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on April 4, 2022 after a review of 172 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 AngioDynamics, Inc. devices

FDA 510(k) Submission Details - K213388

510(k) Number K213388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2021
Decision Date April 04, 2022
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 85
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K213388.
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
K250013 · Control Medical Technology, Inc. / Dba Ventiv Scientific · Mar 2025
AlphaVac MMA F1885 System (H787253020)
K240397 · AngioDynamics, Inc. · Apr 2024
JETi™Hydrodynamic Thrombectomy System
K232458 · Abbott Medical · Dec 2023
JETi AIO Peripheral Thrombectomy System
K213565 · Walk Vascular, LLC · Feb 2022
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · Merit Medical Systems, Inc. · Nov 2021
Thrombuster II Aspiration Catheter
K213166 · Kaneka Medical America, LLC · Oct 2021