Cleared Special

K233815 - ClotTriever Sheath

K233815 is the FDA 510(k) clearance for ClotTriever Sheath by Inari Medical, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 18-day FDA review.

K233815 · Inari Medical, Inc. · Cardiovascular device
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Dec 2023
Decision
18d
Days
Class 2
Risk

K233815 is an FDA 510(k) clearance for the ClotTriever Sheath. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on December 18, 2023 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inari Medical, Inc. devices

Submission Details

510(k) Number K233815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2023
Decision Date December 18, 2023
Days to Decision 18 days
Submission Type Special
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
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K233815.
VenaCore Thrombectomy Catheter (46-101)
K234034 · Inari Medical, Inc. · Feb 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · Penumbra, Inc. · Feb 2024
Cleaner™ Pro Thrombectomy System
K232679 · Argon Medical Devices, Inc. · Jan 2024
Aventus Thrombectomy System
K232730 · Inquis Medical · Nov 2023
ICHOR 14F Embolectomy System
K230743 · Ichor · Sep 2023
Triever20 Curve (21-201)
K231848 · Inari Medical, Inc. · Jul 2023