OTD — Endovascular Suturing System Class II
Classification Details
- Product Code
- OTD
- Device Class
- Class II
- Regulation Number
- 870.3460
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
Provides fixation and sealing between and endovascular graft and the native artery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182957 | medtronic vascular | Heli-FX EndoAnchor System | November 21, 2018 |
| K171427 | medtronic vascular | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | June 13, 2017 |
| K141041 | aptus endosystems | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | May 16, 2014 |
| K140036 | aptus endosystems | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLEC | February 6, 2014 |
| K130677 | aptus endosystems | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | April 12, 2013 |
| K121168 | aptus endosystems | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | August 8, 2012 |
| DEN100026 | aptus endosystems | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAP | November 21, 2011 |