FDA 510(k)

pVasc Net Mechanical Thrombectomy Device

K-Number: K254211 · 2026-08-05

Decision Date2026-08-05

Product Code

DecisionSubstantially Equivalent

Device Summary

pVasc Net Mechanical 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 2026-08-05 under 510(k) number K254211. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pVasc Net Mechanical Thrombectomy Device?

pVasc Net Mechanical Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Vesalio, Inc.. The 510(k) number is K254211.

When did pVasc Net Mechanical Thrombectomy Device receive FDA 510(k) clearance?

pVasc Net Mechanical Thrombectomy Device received FDA 510(k) clearance on 2026-08-05, under 510(k) number K254211.

Who is the listed applicant for pVasc Net Mechanical Thrombectomy Device?

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

Related Clinical Trials

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Other records listing Vesalio, Inc. as applicant

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Official Source

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