Cleared Traditional

ICHOR 14F Embolectomy System (K230743) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 119
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