Cleared Traditional

Aventus Thrombectomy System (IM-2001/IM-0002) (K240117) - FDA 510(k) Clearance

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

K240117 · Inquis Medical · Cardiovascular device
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Mar 2024
Decision
59d
Days
Class 2
Risk

K240117 is an FDA 510(k) clearance for the Aventus Thrombectomy System (IM-2001/IM-0002). Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on March 15, 2024 after a review of 59 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 Inquis Medical devices

Submission Details

510(k) Number K240117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2024
Decision Date March 15, 2024
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral 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 - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 118
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K240117.
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
K241207 · Devoro Medical, Inc. · May 2024
ICE Aspiration System
K234073 · Expanse Medical, Inc. · Apr 2024
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister
K233909 · Argon Medical Devices, Inc. · Mar 2024
VenaCore Thrombectomy Catheter (46-101)
K234034 · Inari Medical, Inc. · Feb 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · Penumbra, Inc. · Feb 2024
Cleaner™ Pro Thrombectomy System
K232679 · Argon Medical Devices, Inc. · Jan 2024