Cleared Traditional

WOLF Thrombectomy V System (K200101) - FDA 510(k) Clearance

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

K200101 · Devoro Medical, Inc. · Cardiovascular device
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Apr 2020
Decision
101d
Days
Class 2
Risk

K200101 is an FDA 510(k) clearance for the WOLF Thrombectomy V System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Devoro Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on April 27, 2020 after a review of 101 days - within the typical 510(k) review window.

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 Devoro Medical, Inc. devices

Submission Details

510(k) Number K200101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2020
Decision Date April 27, 2020
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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

Northwest Clinical Research Group, Inc.
Roberta Hines

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 119
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K200101.
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · Penumbra, Inc. · Aug 2020
CAPERE Thrombectomy System
K201216 · Vascular Medcure, Inc. · Jul 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · Penumbra, Inc. · May 2020
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · Penumbra, Inc. · Apr 2020
Indigo Aspiration System – Lightning Aspiration Tubing
K193244 · Penumbra, Inc. · Mar 2020
Capere Thrombectomy System
K200314 · Vascular Medcure, Inc. · Mar 2020