# OTD: Endovascular Suturing System

- Device class: 2; regulation: 21 CFR 870.3460; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 2
- 2017: 1
- 2018: 1

## Most-cited predicates
- DEN100026: Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette (2011), cited by 5
- K121168: Aptus 18FR Helifx Guide-22 Deflectable Length (2012), cited by 4
- K130677: Aptus Heli-FX Aortic Securement System (2013), cited by 3
- K140036: Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with (2014), cited by 2
- K171427: Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (2017), cited by 1
- K141041: Aptus Heli-FX Ancillary Endoanchor Cassette (2014), cited by 1

Source page: https://510kreport.com/product-code/OTD
Data by year (CSV): https://510kreport.com/product-code/OTD.csv