Cleared Traditional

K240397 - AlphaVac MMA F1885 System (H787253020) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240397 · AngioDynamics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2024
Decision
52d
Days
Class 2
Risk

K240397 is an FDA 510(k) clearance for the AlphaVac MMA F1885 System (H787253020). 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 1, 2024 after a review of 52 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 K240397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2024
Decision Date April 01, 2024
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 91
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K240397.
Liberant™ RX Aspiration Catheter
K253589 · Medtronic Interventional Vascular, Inc. · Apr 2026
FLOWRUNNER Aspiration System
K254208 · Expanse Medical, Inc. · Mar 2026
Aventus Thrombectomy System
K253925 · Inquis Medical · Jan 2026
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · AngioDynamics, Inc. · Nov 2025
Vesalio Peripheral System
K251312 · Vesalio, Inc. · Oct 2025
FLOWRUNNER Aspiration System
K251488 · Expanse Medical, Inc. · Jul 2025