Cleared Traditional

K182835 - WOLF Thrombectomy Device

K182835 is the FDA 510(k) clearance for WOLF Thrombectomy Device by 880 Medical, LLC. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K182835 · 880 Medical, LLC · Cardiovascular device
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Mar 2019
Decision
169d
Days
Class 2
Risk

K182835 is an FDA 510(k) clearance for the WOLF Thrombectomy Device. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by 880 Medical, LLC (Fremont, US). The FDA issued a Cleared decision on March 27, 2019 after a review of 169 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 880 Medical, LLC devices

Submission Details

510(k) Number K182835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2018
Decision Date March 27, 2019
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K182835.
FlowTriever Retrieval/Aspiration System
K191710 · Inari Medical · Sep 2019
ClotTriever Thrombectomy System
K192036 · Inari Medical · Aug 2019
FlowTriever Retrieval/Aspiration System
K191368 · Inari Medical · Jun 2019
CAPERE Thrombectomy System
K183179 · Vascular Medcure, Inc. · Feb 2019
The ICHOR Panacea Vascular Embolectomy Catheter System
K182167 · Ichor Vascular, Inc. · Dec 2018
FlowTriever Retrieval/Aspiration System
K183198 · Inari Medical · Dec 2018