# Endovascular Engineering

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 4 (2023–2026): 4 510(k) clearances
- Names in FDA's records: Endovascular Engineering (2); Endovascular Engineering, Inc. (2)
- Product codes: QEW (3), SHJ (1)
- 510(k) review time since 2016: median 93 days, against 74 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Inari Medical, Inc.: 1 (https://510kreport.com/company/inari-medical)
- Argon Medical Devices, Inc.: 1 (https://510kreport.com/company/argon-medical-devices)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)

## Its most-cited devices
- K223891: Cobra Catheter System (2023), cited by 1
- K252956: Helo Thrombectomy System (2025), cited by 1

## Recent decisions
- K253717: Helo™ Return (Oct 11, 2026)
- K261800: Helo Max Thrombectomy System (HEL2090) (Sep 3, 2026)
- K252956: Helo Thrombectomy System (Dec 18, 2025)
- K223891: Cobra Catheter System (Feb 15, 2023)

Source page: https://510kreport.com/company/endovascular-engineering