Cleared Traditional

K163549 - ClotTriever Thrombectomy System

K163549 is an FDA 510(k) clearance for ClotTriever Thrombectomy System, manufactured by Inari Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K163549 · Inari Medical, Inc. · Cardiovascular device
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Feb 2017
Decision
62d
Days
Class 2
Risk

K163549 is an FDA 510(k) clearance for the ClotTriever Thrombectomy 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 February 16, 2017 after a review of 62 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

FDA 510(k) Submission Details - K163549

510(k) Number K163549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date February 16, 2017
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 136
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K163549.
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · Inari Medical · Feb 2018
V2K Rinspiration System
K172716 · V2k Medical, Inc. · Jan 2018
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
K173470 · Inari Medical · Dec 2017
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
K162970 · Inari Medical · Nov 2016
Penumbra Aspiration System
K161506 · Penumbra, Inc. · Sep 2016
INDIGO Aspiration System
K161523 · Penumbra, Inc. · Jul 2016