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Endovascular Suturing System

FDA product code OTD · Class 2 · Cardiovascular

36

Registered devices

1,181

Adverse events

1

Recalls

7

510(k) clearances

Devices with this code

Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ Ancillary EndoAnchor™ Cassette — MEDTRONIC VASCULAR, INC.APTUS Heli-FX® — MEDTRONIC, INC.Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC VASCULAR, INC.APTUS Heli-FX® — MEDTRONIC VASCULAR, INC.APTUS Heli-FX® — MEDTRONIC VASCULAR, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC VASCULAR, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.APTUS Heli-FX® — MEDTRONIC VASCULAR, INC.APTUS Heli-FX® — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.APTUS Heli-FX® — MEDTRONIC VASCULAR, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC.

Recent recalls

Date	Firm	Reason
2017-09-13	Medtronic Vascular, Inc.	It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.