# NTE: Temporary Carotid Catheter For Embolic Capture

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 43 days (middle half 30–100)
- Recalls: 13 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 3
- 2014: 1
- 2015: 3
- 2016: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2

## Most-cited predicates
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System (2004), cited by 7
- K052659: Spiderx Embolic Protection Device (2006), cited by 4
- K090665: Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19 (2009), cited by 3
- K081523: Emboshield NAV6 Embolic Protection System (2008), cited by 3
- K052166: Modification to:  RX Accunet Embolic Protection System (2005), cited by 3
- K083300: Gore Flow Reversal System (2009), cited by 3
- K063204: Spiderfx Embolic Protection Device (2006), cited by 3
- K101651: Angioguard XP Emboli Capture Guidewire, Angioguard RX Emboli Capture Guidewire (2010), cited by 2
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid (2007), cited by 2
- K111010: Spiderfx Embolic Protection Device (2011), cited by 2

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