Cleared Traditional

Aventus Thrombectomy System (K232730) - FDA 510(k) Clearance

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

K232730 · Inquis Medical · Cardiovascular device
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Nov 2023
Decision
55d
Days
Class 2
Risk

K232730 is an FDA 510(k) clearance for the Aventus Thrombectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inquis Medical (Redwood City, US). The FDA issued a Cleared decision on November 1, 2023 after a review of 55 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 K232730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2023
Decision Date November 01, 2023
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 Consultant

Mojgan Saadat
Mojgan Saadat

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K232730.
Indigo® Aspiration System - Lightning® Flash
K240030 · Penumbra, Inc. · Feb 2024
Cleaner™ Pro Thrombectomy System
K232679 · Argon Medical Devices, Inc. · Jan 2024
ClotTriever Sheath
K233815 · Inari Medical, Inc. · Dec 2023
ICHOR 14F Embolectomy System
K230743 · Ichor · Sep 2023
Triever20 Curve (21-201)
K231848 · Inari Medical, Inc. · Jul 2023
Pounce™ Thrombectomy System
K231022 · Surmodics,Inc. · Jun 2023