APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH - Aptus Heli-Fx Guide - 22cm Deflectable Length

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K140036 ↗

FDA Product Code

OTD

Models / Variants

Aptus Heli-Fx Guide - 22cm Deflectable Length

Aptus Heli-Fx Guide - 28cm Deflectable Length

Aptus Heli-Fx Applier With

Device Class

Class II

Regulation

21 CFR Part 870.3460

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Aptus Heli-Fx Aortic Securement System

  Class II

  FDA 510(k) K130677 Active Cleared 12 Apr 2013

• Aptus Heli-Fx Ancillary Endoanchor Cassette

  Class II

  FDA 510(k) K141041 Active Cleared 16 May 2014

• Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette

  Class II

  FDA De Novo DEN100026 Active Cleared 21 Nov 2011 FDA 510(k)

• Aptus 18Fr Helifx Guide-22 Deflectable Length

  Class II

  FDA 510(k) K121168 Active Cleared 8 Aug 2012