Cleared Traditional

K230743 - ICHOR 14F Embolectomy System

K230743 is an FDA 510(k) clearance for ICHOR 14F Embolectomy System, manufactured by Ichor. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K230743 · Ichor · Cardiovascular device
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Sep 2023
Decision
173d
Days
Class 2
Risk

K230743 is an FDA 510(k) clearance for the ICHOR 14F Embolectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Ichor (Boca Raton, US). The FDA issued a Cleared decision on September 5, 2023 after a review of 173 days - an extended review 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: 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 Ichor devices

FDA 510(k) Submission Details - K230743

510(k) Number K230743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2023
Decision Date September 05, 2023
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
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 131
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K230743.
Cleaner™ Pro Thrombectomy System
K232679 · Argon Medical Devices, Inc. · Jan 2024
ClotTriever Sheath
K233815 · Inari Medical, Inc. · Dec 2023
Aventus Thrombectomy System
K232730 · Inquis Medical · Nov 2023
Triever20 Curve (21-201)
K231848 · Inari Medical, Inc. · Jul 2023
Pounce™ Thrombectomy System
K231022 · Surmodics,Inc. · Jun 2023
Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)
K223929 · Innova Vascular, Inc. · Jun 2023