Cleared Traditional

K233917 - ICHOR 7F Embolectomy System (ICH-7F)

K233917 is an FDA 510(k) clearance for ICHOR 7F Embolectomy System (ICH-7F), manufactured by Ichor. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K233917 · Ichor · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2024
Decision
219d
Days
Class 2
Risk

K233917 is an FDA 510(k) clearance for the ICHOR 7F Embolectomy System (ICH-7F). 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 July 18, 2024 after a review of 219 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.

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FDA 510(k) Submission Details - K233917

510(k) Number K233917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2023
Decision Date July 18, 2024
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
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 K233917.
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K242075 · Penumbra, Inc. · Sep 2024
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · Surmodics,Inc. · Sep 2024
Indigo® Aspiration System – Aspiration Catheter 6X
K242319 · Penumbra, Inc. · Sep 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
ICE Aspiration System
K234073 · Expanse Medical, Inc. · Apr 2024