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FDA 510(k)

NeVa PV Thrombectomy Device

K-Number: K253407 · 2025-11-24

ApplicantVesalio, Inc.
Decision Date2025-11-24
Product CodeQEX
Advisory CommitteeCV
DecisionUnknown

Device Summary

NeVa PV Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K253407. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Vesalio, Inc.. The 510(k) number is K253407.

When did NeVa PV Thrombectomy Device receive FDA 510(k) clearance?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2025-11-24, under 510(k) number K253407.

Who is the listed applicant for NeVa PV Thrombectomy Device?

The FDA 510(k) record lists Vesalio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeVa PV Thrombectomy Device?

The FDA product code for NeVa PV Thrombectomy Device is QEX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04969471NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)ACTIVE_NOT_RECRUITINGNCT06893588Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEntsRECRUITING

Other records listing Vesalio, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254211pVasc Net Mechanical Thrombectomy DeviceK251097V-DAC CatheterK251006NeVasc Aspiration SystemK251312Vesalio Peripheral SystemK201085NeVa PV Thrombectomy Device

Related Devices (Code: QEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171493MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc.K163618INDIGO Aspiration SystemPenumbra, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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