Skip to content

Aptus Heli-Fx Aortic Securement System

by Aptus Endosystems, Inc.

510(k) K130677

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK130677 Date12 Apr 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
OTD
Device Class
Class II
Regulation
21 CFR Part 870.3460
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 Aptus Heli-Fx Aortic Securement System is an Endovascular Suturing System, classified as a device with a product code of OTD. It is used in the medical specialty of Cardiovascular. The system is designed to provide aortic securement. As stated in its device type and definition, it is an Endovascular Suturing System.

The Aptus Heli-Fx Aortic Securement System is supplied with a device class of 2 and is regulated under the regulation number 870.3460. It has been cleared by the FDA with a 510(k) clearance, specifically with the k number K130677. The system is intended for use in a cardiovascular setting and is designed to provide securement for endovascular aneurysm repair (EVAR).

Other devices from Aptus Endosystems, Inc.

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 Aptus Heli-Fx Aortic Securement System used for?

    The system is used for endovascular aneurysm repair (EVAR) to provide aortic securement in a cardiovascular setting.

  • What is the regulatory classification of the Aptus Heli-Fx system?

    The system is classified as a device with a product code of OTD and is regulated under the regulation number 870.3460.

  • Is the Aptus Heli-Fx system cleared by the FDA?

    Yes, the system has been cleared by the FDA with a 510(k) clearance, specifically with the k number K130677, indicating it is substantially equivalent to a predicate device.