Cleared Traditional

WOLF Thrombectomy System, 6F (K210530) - FDA 510(k) Clearance

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

K210530 · Devoro Medical, Inc. · Cardiovascular device
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Aug 2021
Decision
184d
Days
Class 2
Risk

K210530 is an FDA 510(k) clearance for the WOLF Thrombectomy System, 6F. 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 August 27, 2021 after a review of 184 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 Devoro Medical, Inc. devices

Submission Details

510(k) Number K210530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2021
Decision Date August 27, 2021
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 K210530.
Cleaner Plus Thrombectomy System
K211798 · Argon Medical Devices, Inc. · Feb 2022
WOLF Thrombectomy System, 14F
K210911 · Devoro Medical, Inc. · Oct 2021
ClotTriever Thrombectomy System
K212632 · Inari Medical, Inc. · Oct 2021
Pounce Thrombectomy System
K211492 · Surmodics,Inc. · Jul 2021
ClotTriever Thrombectomy System
K210689 · Inari Medical, Inc. · May 2021
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
K211013 · Inari Medical, Inc. · Apr 2021