Cleared Special

K183198 - FlowTriever Retrieval/Aspiration System

K183198 is the FDA 510(k) clearance for FlowTriever Retrieval/Aspiration System by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K183198 · Inari Medical · Cardiovascular device
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Dec 2018
Decision
28d
Days
Class 2
Risk

K183198 is an FDA 510(k) clearance for the FlowTriever Retrieval/Aspiration System. 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 December 17, 2018 after a review of 28 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 devices

Submission Details

510(k) Number K183198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date December 17, 2018
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K183198.
WOLF Thrombectomy Device
K182835 · 880 Medical, LLC · Mar 2019
CAPERE Thrombectomy System
K183179 · Vascular Medcure, Inc. · Feb 2019
The ICHOR Panacea Vascular Embolectomy Catheter System
K182167 · Ichor Vascular, Inc. · Dec 2018
FlowTriever Retrieval/Aspiration System
K182233 · Inari Medical · Oct 2018
ClotTriever Thrombectomy System
K182531 · Inari Medical · Oct 2018
FlowTriever Retrieval/Aspiration System
K181694 · Inari Medical · Jul 2018