Product code OTD
- Device name
- Endovascular Suturing System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3460
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Provides fixation and sealing between and endovascular graft and the native artery.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018-11-21 |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic Vascular, Inc. | 2017-06-13 |
| K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | Aptus Endosystems | 2014-05-16 |
| K140036 | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH | Aptus Endosystems, Inc. | 2014-02-06 |
| K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | Aptus Endosystems, Inc. | 2013-04-12 |
| K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | Aptus Endosystems, Inc. | 2012-08-08 |
| DEN100026 | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE | Aptus Endosystems, Inc. | 2011-11-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000645120 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2022-10-22 |
| 00763000645137 | Heli-FX™ EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2022-10-22 |
| 00763000645144 | Heli-FX™ Thoracic EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2022-10-22 |
| 00763000645151 | Heli-FX™ Thoracic EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2022-10-22 |
| 00763000645168 | Heli-FX™ Thoracic EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2022-10-22 |
| 00763000645175 | Heli-FX™ Thoracic EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2022-10-22 |
| 00763000645182 | Heli-FX™ Ancillary EndoAnchor™ Cassette | MEDTRONIC VASCULAR, INC. | 2022-10-22 |
| 00763000645113 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2022-10-22 |
| 00763000225957 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2019-09-16 |
| 00763000225933 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2019-06-29 |
| 00763000225940 | Heli-FX™ EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2019-06-29 |
| 00763000225988 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2019-06-29 |
| 00763000225995 | Heli-FX™ EndoAnchor™ System | MEDTRONIC VASCULAR, INC. | 2019-06-29 |
| 00763000226008 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2019-06-29 |
| 00763000225971 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2019-05-10 |
| 00763000225964 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2019-05-10 |
| 00763000025250 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-11-10 |
| 00763000025267 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-11-10 |
| 00763000025274 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-11-10 |
| 00763000025281 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-11-10 |
| 00763000025298 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-11-10 |
| 00763000006624 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-09-17 |
| 00763000006631 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-09-17 |
| 00763000006655 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-09-17 |
| 00763000006662 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-09-17 |
| 00763000006679 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-09-17 |
| 00763000006617 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-08-06 |
| 00763000006648 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-08-06 |
| 00763000006686 | Heli-FX™ EndoAnchor™ System | MEDTRONIC, INC. | 2017-08-06 |
| 00643169647565 | APTUS Heli-FX® | MEDTRONIC VASCULAR, INC. | 2015-10-21 |