OTD
7 FDA 510(k) clearances · Product code
30 daysmedian time to decision
342 days90th percentile
7clearances measured
FDA profile
- Official device name
- Endovascular Suturing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3460
- Medical specialty
- Cardiovascular
- Flags
- Implant
- FDA definition
- Provides fixation and sealing between and endovascular graft and the native artery.
- Adverse events (MAUDE)
- 2021: 59 · 2022: 52 · 2023: 52 · 2024: 62 · 2025: 56 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE (K141041) | Aptus Endosystems | 2014-05-16 |
| APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH (K140036) | Aptus Endosystems, Inc. | 2014-02-06 |
| APTUS HELI-FX AORTIC SECUREMENT SYSTEM (K130677) | Aptus Endosystems, Inc. | 2013-04-12 |
| APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (K121168) | Aptus Endosystems, Inc. | 2012-08-08 |
| APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE (DEN100026) | Aptus Endosystems, Inc. | 2011-11-21 |
Track OTD automatically
Every clearance here is in the API, with alerts when new ones post.