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Micrus Microcatheter

by Micrus Corp.

510(k) K032624

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 NumberK032624 Date10 Sep 2003ClearedStatusActive

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Micrus Microcatheter is an intravascular diagnostic/vascular diagnostic/therapeutic catheter. It consists of a flexible shaft with a Teflon liner, stainless steel wire reinforcement, a Pebax outer jacket, an atraumatic distal tip with two radiopaque marker bands, and a standard luer hub.

This device is supplied by Micrus Corp. and was cleared via the FDA 510(k) pathway under K032624. It is classified under product code DQO and reviewed by the Cardiovascular advisory committee. The device is intended for intravascular use and is not described as sterile, single-use, reusable, MRI safe, or with specific sizes, storage conditions, or additional authorizations in the provided data.

Other devices from Micrus Corp.

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Micrus Microcatheter used for?

    The Micrus Microcatheter is an intravascular diagnostic/vascular diagnostic/therapeutic catheter designed for use within blood vessels to support diagnostic or therapeutic procedures, as indicated by its classification and intended use for intravascular applications.

  • How is the Micrus Microcatheter supplied and is it sterile or single-use?

    The device is supplied by Micrus Corp., but the provided data does not specify whether it is sterile, single-use, or reusable; therefore, no conclusion can be drawn about its sterility or reuse status based solely on the information given.

  • What materials make up the Micrus Microcatheter?

    The Micrus Microcatheter consists of a flexible shaft with a Teflon liner, stainless steel wire reinforcement, a Pebax outer jacket, an atraumatic distal tip with two radiopaque marker bands, and a standard luer hub, as detailed in its construction description.

  • What regulatory pathway was used for the Micrus Microcatheter?

    The Micrus Microcatheter was cleared via the FDA 510(k) pathway under submission number K032624, as stated in the authorizations and clearance details provided in the device data.

  • What product code and advisory committee reviewed the Micrus Microcatheter?

    The device is classified under product code DQO and was reviewed by the Cardiovascular advisory committee, as indicated in the product code and advisory committee description fields.