# K230402: ENROUTE® Transcarotid Neuroprotection System

- Pathway: 510(k) (Special)
- Applicant: Silk Road Medical
- Decided: Apr 11, 2023 after 55 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003992 (2001). 30 ancestors in all.
No later device cites it as a predicate yet.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153485: ENROUTE Transcarotid Neuroprotection System, Silk Road Medical, Inc. (2016) Summary page 4.

## Recalls of this device
- Jul 9, 2026 · Class I · Z-2978-2026: Potential for arterial sheath tip separation or partial tip separation during use.

## Indications for use
The 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 appropriate anatomy described below: • Adequate femoral venous access • Common carotid artery reference diameter of at least 6mm • Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.

Source page: https://510kreport.com/device/K230402
Methodology: https://510kreport.com/methodology