NeVa PV Thrombectomy Device— 510(k) K253407

Unknown

Vesalio, Inc.

FDA 510(k) clearance K253407 for NeVa PV Thrombectomy Device, Unknown on 2025-11-24. Applicant: Vesalio, Inc.. Device class: 2.

Clearance details

Applicant: Vesalio, Inc.
Product code: Code QEX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-09-30
Decision date: 2025-11-24
Decision: Unknown
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEX

K171493 — MegaVac Mechanical Thrombectomy System2017-08-10
K163618 — INDIGO Aspiration System2017-05-24

More clearances from Vesalio, Inc.

K254211 — pVasc Net Mechanical Thrombectomy Device2026-08-05
K251097 — V-DAC Catheter2026-01-06
K251006 — NeVasc Aspiration System2025-11-10
K251312 — Vesalio Peripheral System2025-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.