Cleared Traditional

K211081 - AlphaVac Multipurpose Mechanical Aspira...

K211081 is the FDA 510(k) clearance for AlphaVac Multipurpose Mechanical Aspira... by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K211081 · AngioDynamics, Inc. · Cardiovascular device
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Jun 2021
Decision
53d
Days
Class 2
Risk

K211081 is an FDA 510(k) clearance for the AlphaVac Multipurpose Mechanical Aspiration (MMA) 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 June 4, 2021 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K211081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date June 04, 2021
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K211081.
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
JETi AIO Peripheral Thrombectomy System
K201998 · Walk Vascular, LLC · Nov 2020
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
K200871 · Control Medical Technology · May 2020
QuickClear Mechanical Thrombectomy System
K193197 · Volcano Atheromed, Inc. · Apr 2020