# K143072: ENROUTE Transcarotid Neuroprotection System

- Pathway: 510(k) (Traditional)
- Applicant: Silk Road Medical, Inc.
- Decided: Feb 9, 2015 after 105 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003992 (2001). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083300: Gore Flow Reversal System, W. L. Gore & Associates, Inc. (2009) Summary page 4.

## Most influential descendants
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own
- K230402: ENROUTE® Transcarotid Neuroprotection System (2023), 0 descendants of its own

## Indications for use
ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below: e Adequate femoral venous access e Common carotid artery reference diameter of at least 6 mm. Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography

Source page: https://510kreport.com/device/K143072
Methodology: https://510kreport.com/methodology