Cleared Traditional

K250088 - FlowTriever2 Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K250088 · Inari Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
58d
Days
Class 2
Risk

K250088 is an FDA 510(k) clearance for the FlowTriever2 Catheter. 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 March 13, 2025 after a review of 58 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.

View all Inari Medical, Inc. devices

Submission Details

510(k) Number K250088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2025
Decision Date March 13, 2025
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

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
NCT05560763 Completed Interventional Industry-sponsored

FlowTriever2 Pulmonary Embolectomy Clinical Study

FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2

50
Patients (actual)
7
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Inari Medical (industry)
Started 2023-02-14 → Primary completion 2024-09-09
Primary outcome
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
Secondary outcome
Secondary Safety Endpoint: Number of Patient Mortalities
View full study on ClinicalTrials.gov

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 140
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K250088.
INDIGO® Aspiration System – INDIGO Link
K260599 · Penumbra, Inc. · Apr 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · Penumbra, Inc. · Feb 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister
K260028 · Argon Medical Devices, Inc. · Feb 2026
RoVo Mechanical Thrombectomy System
K253730 · Verge Medical, Inc. · Jan 2026
Sangria™ Thrombectomy System
K251207 · Avantec Vascular Corporation · Jan 2026
Helo Thrombectomy System
K252956 · Endovascular Engineering, Inc. · Dec 2025