# Silk Road Medical, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 6 (2013–2023): 6 510(k) clearances
- Names in FDA's records: Silk Road Medical, Inc. (5); Silk Road Medical (1)
- Product codes: NTE (3), DQY (2), LIT (1)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Penumbra, Inc.: 2 (https://510kreport.com/company/penumbra)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Cordis Europa, N.V.: 1 (https://510kreport.com/company/cordis-europa)

## Its most-cited devices
- K130649: Silk Road Access Catheter (2013), cited by 1
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), cited by 1
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), cited by 1

## Recent decisions
- K230402: ENROUTE® Transcarotid Neuroprotection System (Apr 11, 2023)
- K221414: ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter (Sep 2, 2022)
- K153485: ENROUTE Transcarotid Neuroprotection System (Mar 10, 2016)
- K143459: Silk Road Acccess Catheter (Apr 1, 2015)
- K143072: ENROUTE Transcarotid Neuroprotection System (Feb 9, 2015)
- K130649: Silk Road Access Catheter (Nov 1, 2013)

Source page: https://510kreport.com/company/silk-road-medical