Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette— 510(k) K171427

Clearance details

Applicant

Medtronic Vascular, Inc.

Product code

Code OTD

Device class

Class 2

Regulation

21 CFR 870.3460

Advisory panel

Cardiovascular

Date received

2017-05-15

Decision date

2017-06-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Santa Rosa, CA, US

• K182957 — Heli-FX EndoAnchor System2018-11-21
• K141041 — APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE2014-05-16
• K140036 — APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH2014-02-06
• K130677 — APTUS HELI-FX AORTIC SECUREMENT SYSTEM2013-04-12
• K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH2012-08-08

• K171866 — Sentrant Introducer Sheath with Hydrophilic Coating2017-12-20
• K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System2017-06-16
• K161361 — HawkOne Directional Atherectomy System2016-10-14

Death

31

Injury

172

Total

203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-3227-2017 — Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.Class II·Terminated·Medtronic Vascular, Inc.·20170913

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171427.