Cleared Traditional

EMBOGUARD Balloon Guide Catheter (K212340) - FDA 510(k) Clearance

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

K212340 · Neuravi Limited · Neurology device
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Dec 2021
Decision
142d
Days
Class 2
Risk

K212340 is an FDA 510(k) clearance for the EMBOGUARD Balloon Guide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Neuravi Limited (Galway, IE). The FDA issued a Cleared decision on December 17, 2021 after a review of 142 days - within the typical 510(k) review window.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuravi Limited devices

Submission Details

510(k) Number K212340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2021
Decision Date December 17, 2021
Days to Decision 142 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
6d faster than avg
Panel avg: 148d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 Neurology devices follow this clearance model.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K212340.
FUBUKI XF Neurovascular Long Sheath
K213589 · Asahi Intecc Co., Ltd. · Mar 2022
CerusEndo Microcatheter (027)
K213314 · Cerus Endovascular, Inc. · Mar 2022
Micro Catheter
K202926 · Shanghai Heartcare Medical Technology Co., Ltd. · Feb 2022
MIVI Q Distal Access Catheter
K212402 · Mivi Neuroscience, Inc. · Dec 2021
Branchor Balloon Guide Catheter
K203723 · Asahi Intecc Co., Ltd. · Dec 2021
Trevo Trak 21 Microcatheter
K211594 · Stryker Neurovascular · Nov 2021