# Vesalio, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 6 (2021–2026): 6 510(k) clearances
- Names in FDA's records: Vesalio, Inc. (5); Vesalio (1)
- Product codes: QEZ (1), NRY (1), QJP (1), QEW (1), QEX (1)
- 510(k) review time since 2016: median 245 days, against 119 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 7 (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
- Volcano Atheromed, Inc.: 1 (https://510kreport.com/company/volcano-atheromed)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Capture Vascular, Inc.: 1 (https://510kreport.com/company/capture-vascular)

## Its most-cited devices
- K201085: NeVa PV Thrombectomy Device (2021), cited by 2

## Recent decisions
- K254211: pVasc Net Mechanical Thrombectomy Device (Aug 5, 2026)
- K251097: V-DAC Catheter (Jan 6, 2026)
- K253407: NeVa PV Thrombectomy Device (Nov 24, 2025)
- K251006: NeVasc Aspiration System (Nov 10, 2025)
- K251312: Vesalio Peripheral System (Oct 24, 2025)
- K201085: NeVa PV Thrombectomy Device (Jan 15, 2021)

Source page: https://510kreport.com/company/vesalio