Endovascular Suturing System
FDA product code OTD · Class II (moderate risk) · 21 CFR 870.3460 · Cardiovascular
Provides fixation and sealing between and endovascular graft and the native artery.
6510(k) clearances
0PMA approvals
1recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182957 | Heli-FX EndoAnchor SystemOTD · Special | Medtronic Vascular, Inc. | 11/21/2018SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | Medtronic Vascular, Inc. | 06/13/2017SE |
| K141041 | Aptus Heli-Fx Ancillary Endoanchor CassetteOTD · Special | Aptus Endosystems | 05/16/2014SE |
| K140036 | Aptus Heli-Fx Guide - 22CM Deflectable Length; Aptus Heli-Fx Guide - 28CM Deflectable…OTD · Special | Aptus Endosystems, Inc. | 02/06/2014SE |
| K130677 | Aptus Heli-Fx Aortic Securement SystemOTD · Special | Aptus Endosystems, Inc. | 04/12/2013SE |
| K121168 | Aptus 18FR Helifx GUIDE-22 Deflectable LengthOTD · Traditional | Aptus Endosystems, Inc. | 08/08/2012SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3227-2017 Class II | Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42…It was determined that the deflection length indicated on the Guide catheter handle does not match the label… | Medtronic Vascular, Inc. | 09/13/2017Terminated |