Cleared Traditional

K143563 - Infusion Aspiration Catheter System

K143563 is an FDA 510(k) clearance for Infusion Aspiration Catheter 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 49-day FDA review.

K143563 · Inari Medical, Inc. · Cardiovascular device
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Feb 2015
Decision
49d
Days
Class 2
Risk

K143563 is an FDA 510(k) clearance for the Infusion Aspiration Catheter System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on February 3, 2015 after a review of 49 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 - K143563

510(k) Number K143563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2014
Decision Date February 03, 2015
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K143563.
ZelanteDVT Thrombectomy Set
K151313 · Boston Scientific Corporation · Sep 2015
Retraction Aspirator
K152097 · Inari Medical · Aug 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · Penumbra, Inc. · May 2015
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K141617 · Rex Medical, L.P. · Nov 2014
ANGIOJET ULTRA AVX THROMBECTOMY SET
K133629 · Possis Medical, Inc. · Feb 2014
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · Codman & Shurtleff, Inc. · Aug 2013