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Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter

by Micro Therapeutics Inc Dba Ev3 Neurovascular

510(k) K150107

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150107 Date29 Jul 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arc Intracranial Support Catheter and Arc Mini Intracranial Support Catheter are devices designed for the introduction of interventional devices into the peripheral and neurovasculature. They are specifically designed for use in neurovascular procedures, particularly in providing support during endovascular interventions for acute ischemic stroke.

These catheters are supplied as sterile devices and are intended for single-use. They are available in multiple sizes as specified by the manufacturer. The device has received FDA 510(k) clearance with the product code DQY and is classified under the cardiovascular advisory committee.

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