510(k) clearances

pVasc Net Mechanical Thrombectomy Device

Vesalio, Inc. · Unknown

K254211Substantially EquivalentSpecial
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Third party flag
N
City
San Diego
Advisory committee description
Unknown
Address 1
2305 Historic Decatur Rd.
Address 2
Suite 100
Statement or summary
Summary
Zip code
92106
Applicant
Vesalio, Inc.
Decision date
2026-08-05
Decision code
SESE
Country code
US
Device name
pVasc Net Mechanical Thrombectomy Device
Contact
Sharon Shachar
K number
K254211
State
CA
Date received
2025-12-29
Review advisory committee
CV
Postal code
92106
Decision description
Substantially Equivalent
Clearance type
Special
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.