Cleared Traditional

K182167 - The ICHOR Panacea Vascular Embolectomy ...

K182167 is the FDA 510(k) clearance for The ICHOR Panacea Vascular Embolectomy ... by Ichor Vascular, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K182167 · Ichor Vascular, Inc. · Cardiovascular device
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Dec 2018
Decision
133d
Days
Class 2
Risk

K182167 is an FDA 510(k) clearance for the The ICHOR Panacea Vascular Embolectomy Catheter System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Ichor Vascular, Inc. (Toledo, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 133 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 Ichor Vascular, Inc. devices

Submission Details

510(k) Number K182167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date December 21, 2018
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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

Namsa
Angela Mallery

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 K182167.
FlowTriever Retrieval/Aspiration System
K191368 · Inari Medical · Jun 2019
WOLF Thrombectomy Device
K182835 · 880 Medical, LLC · Mar 2019
CAPERE Thrombectomy System
K183179 · Vascular Medcure, Inc. · Feb 2019
FlowTriever Retrieval/Aspiration System
K183198 · Inari Medical · Dec 2018
FlowTriever Retrieval/Aspiration System
K182233 · Inari Medical · Oct 2018
ClotTriever Thrombectomy System
K182531 · Inari Medical · Oct 2018