Cleared Traditional

K211120 - ERIC Retrieval Device

K211120 is an FDA 510(k) clearance for ERIC Retrieval Device, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code NRY cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K211120 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
350d
Days
Class 2
Risk

K211120 is an FDA 510(k) clearance for the ERIC Retrieval Device. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on March 31, 2022 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K211120

510(k) Number K211120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2021
Decision Date March 31, 2022
Days to Decision 350 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 149d · This submission: 350d
Pathway characteristics
Predicate-based equivalence.

NRY Device Classification - Class 2, Special Controls

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03776877 Unknown Observational

Endovascular Treatment in Ischemic Stroke Follow-up Evaluation

Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

4000
Patients (est.)
16
Sites
Condition studied Stroke, Acute
Eligibility All sexes · 18 Years+
Principal investigator Bertrand Larpergue, MD
Sponsor Hopital Foch
Started 2018-06-26 → Primary completion 2022-12-01
Primary outcome
Clinical outcome
Secondary outcome
Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)
View full study on ClinicalTrials.gov

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 116
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K211120.
APRO 70 Catheter and Alembic Aspiration Tubing
K223545 · Alembic, LLC · Feb 2023
Penumbra System (Reperfusion Catheter RED 43)
K222808 · Penumbra, Inc. · Dec 2022
Tigertriever 13 Revascularization Device
K220808 · Rapid Medical , Ltd. · Jul 2022
Esperance Aspiration Catheter System
K211697 · Wallaby Medical · Nov 2021
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
K212908 · Neuravi, Ltd. · Oct 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654 · Penumbra, Inc. · Aug 2021
K211120 · ERIC Retrieval Device
Download PDF FDA Summary MicroVention, Inc.