Cleared Special

FlowTriever Retrieval/Aspiration System (K181325) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K181325 · Inari Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
30d
Days
Class 2
Risk

K181325 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, Inc. (Irvine, US). The FDA issued a Cleared decision on June 17, 2018 after a review of 30 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 K181325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2018
Decision Date June 17, 2018
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02692586 Completed Interventional Industry-sponsored

FlowTriever Pulmonary Embolectomy Clinical Study

106
Patients (actual)
18
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism; Acute Pulmonary Embolism; Submassive Pulmonary Embolism; Massive Pulmonary Embolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Kenneth Rosenfield, MD
Sponsor Inari Medical (industry)
Started 2016-04-01 → Primary completion 2017-11-01
Primary outcome
Change in RV/LV Ratio
View full study on ClinicalTrials.gov

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K181325.
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
CAPERE Thrombectomy System
K180722 · Kp Medcure, Inc. · Jun 2018
FlowTriever Retrieval/Aspiration System
K180466 · Inari Medical, Inc. · May 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
K180412 · Penumbra, Inc. · May 2018