Cleared Traditional

K234073 - ICE Aspiration System

K234073 is an FDA 510(k) clearance for ICE Aspiration System, manufactured by Expanse Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K234073 · Expanse Medical, Inc. · Cardiovascular device
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Apr 2024
Decision
119d
Days
Class 2
Risk

K234073 is an FDA 510(k) clearance for the ICE Aspiration System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Expanse Medical, Inc. (Pleasonton, US). The FDA issued a Cleared decision on April 19, 2024 after a review of 119 days - within the typical 510(k) review window.

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 Expanse Medical, Inc. devices

FDA 510(k) Submission Details - K234073

510(k) Number K234073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date April 19, 2024
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K234073.
ICHOR 7F Embolectomy System (ICH-7F)
K233917 · Ichor · Jul 2024
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
K241399 · Penumbra, Inc. · Jun 2024
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
K241207 · Devoro Medical, Inc. · May 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
Aventus Thrombectomy System (IM-2001/IM-0002)
K240117 · Inquis Medical · Mar 2024
VenaCore Thrombectomy Catheter (46-101)
K234034 · Inari Medical, Inc. · Feb 2024