Cleared Traditional

NeVa PV Thrombectomy Device (K201085) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201085 · Vesalio · Cardiovascular device
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Jan 2021
Decision
267d
Days
Class 2
Risk

K201085 is an FDA 510(k) clearance for the NeVa PV Thrombectomy Device. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Vesalio (Nashville, US). The FDA issued a Cleared decision on January 15, 2021 after a review of 267 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vesalio devices

Submission Details

510(k) Number K201085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2020
Decision Date January 15, 2021
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
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 Consultant

Biologics and Medical Device Consulting Group
Sigi Caron

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 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K201085.
Triever Catheters
K210195 · Inari Medical · Feb 2021
ClotTriever Thrombectomy System
K210190 · Irani Medical, Inc. · Feb 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
K210083 · Penumbra, Inc. · Feb 2021
ReVene Thrombectomy Catheter
K201705 · Vetex Medical, Ltd. · Dec 2020
CAPERE Thrombectomy System
K203476 · Vascular Medcure, Inc. · Dec 2020
FlowTriever Retrieval/Aspiration System
K202345 · Inari Medical · Dec 2020