Cleared Traditional

Neurescue device (K210358) - FDA 510(k) Clearance

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

K210358 · Neurescue Aps · Cardiovascular device
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May 2021
Decision
102d
Days
Class 2
Risk

K210358 is an FDA 510(k) clearance for the Neurescue device. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Neurescue Aps (Copenhagen, DK). The FDA issued a Cleared decision on May 21, 2021 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Neurescue Aps devices

Submission Details

510(k) Number K210358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date May 21, 2021
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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

CardioMed Device Consultants, LLC
Semih Oktay

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 - MJN Catheter, Intravascular Occluding, Temporary

All 24
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K210358.
Fogarty Occlusion Catheter
K211610 · Edwards Lifesciences, LLC · Feb 2022
RenovoCath
K212324 · Renovorx, Inc. · Aug 2021
AortaSTAT Occlusion Device
K210602 · Renalpro Medical, Inc. · Jul 2021
COBRA-OS Kit
K201652 · Front Line Medical Technologies, Inc. · Feb 2021
Bridge Occlusion Balloon
K203540 · Spectranetics, Inc. · Dec 2020
pREBOA-PRO Catheter
K200459 · Prytime Medical Devices, Inc. · Jun 2020