Cleared Traditional

K191710 - FlowTriever Retrieval/Aspiration System

K191710 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 Traditional 510(k) pathway after a 71-day FDA review.

K191710 · Inari Medical · Cardiovascular device
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Sep 2019
Decision
71d
Days
Class 2
Risk

K191710 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 September 5, 2019 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K191710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date September 05, 2019
Days to Decision 71 days
Submission Type Traditional
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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K191710.
Indigo Aspiration System
K192833 · Penumbra, Inc. · Dec 2019
CAPERE Thrombectomy System
K192935 · Vascular Medcure, Inc. · Nov 2019
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
K192332 · Inari Medical · Sep 2019
ClotTriever Thrombectomy System
K192036 · Inari Medical · Aug 2019
FlowTriever Retrieval/Aspiration System
K191368 · Inari Medical · Jun 2019
WOLF Thrombectomy Device
K182835 · 880 Medical, LLC · Mar 2019