NeVa PV Thrombectomy Device

FDA 510(k) K253407 · Vesalio, Inc.

Unknown

510(k) numberK253407

Submission

Device name
NeVa PV Thrombectomy Device
Applicant
Vesalio, Inc.
San Diego, CA, US
Received
September 30, 2025
Decision date
November 24, 2025
Decision
Unknown (SESU)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEX – Coronary Mechanical Thrombectomy With Aspiration
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.

Other 510(k)s with product code QEX

510(k)DeviceApplicantDecision
K171493MegaVac Mechanical Thrombectomy SystemQEX · Special Capture Vascular, Inc.08/10/2017SE
K163618INDIGO Aspiration SystemQEX · Traditional Penumbra, Inc.05/24/2017SESU

More from Penumbra, Inc.

510(k)DeviceDecision
K254211pVasc Net Mechanical Thrombectomy Device · Special 08/05/2026SE
K251097V-DAC CatheterQJP · Traditional 01/06/2026SE
K251006NeVasc Aspiration SystemNRY · Traditional 11/10/2025SE
K251312Vesalio Peripheral SystemQEZ · Traditional 10/24/2025SE
K201085NeVa PV Thrombectomy DeviceQEW · Traditional 01/15/2021SE

Questions and answers

When was NeVa PV Thrombectomy Device cleared by the FDA?

NeVa PV Thrombectomy Device (K253407) received a 510(k) decision of Unknown on November 24, 2025, 55 days after the submission was received.

What is the product code of K253407?

The FDA product code is QEX – Coronary Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.