510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K254211Substantially Equivalent

pVasc Net Mechanical Thrombectomy Device

Vesalio, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254211 is the FDA 510(k) clearance record for pVasc Net Mechanical Thrombectomy Device, cleared for Vesalio, Inc. on . FDA records list 6 510(k) clearances for Vesalio, Inc., from to . As of , FDA records show no recalls naming K254211.

Clearance record

Decision date
Received
(219 days to decision)
Review panel
Unknown
Applicant
Vesalio, Inc. 2305 Historic Decatur Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No