Cleared Special

K213402 - Triever24, Triever20

K213402 is an FDA 510(k) clearance for Triever24, manufactured by Inari Medical. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Special 510(k) pathway after a 217-day FDA review.

K213402 · Inari Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
217d
Days
Class 2
Risk

K213402 is an FDA 510(k) clearance for the Triever24, Triever20. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on May 23, 2022 after a review of 217 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K213402

510(k) Number K213402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2021
Decision Date May 23, 2022
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
Pathway characteristics
Modification to existing cleared device.

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 145
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K213402.
Protrieve Sheath
K220415 · Inari Medical, Inc. · Jul 2022
Excipio SV Thrombectomy Device
K221204 · Contego Medical, Inc. · Jun 2022
Aspirex Thrombectomy System
K220270 · C.R. Bard, Inc. · Jun 2022
Prodigy Thrombectomy System
K214114 · Truvic Medical, Inc. · Apr 2022
Artix Thrombectomy Device
K220600 · Inari Medical · Mar 2022
Pounce Thrombectomy System
K220501 · Surmodics,Inc. · Mar 2022
K213402 · Triever24, Triever20
Download PDF FDA Summary Inari Medical