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Lmi Carotid Endarterectomy Shunt Catheter (#'s Ces +9 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983802

by Lucas Medical Inc

Identifiers

510(k) Number
K983802 FDA 510(k)
FDA Product Code
MJN FDA 510(k)
Models / Variants
#'s Ces FDA 510(k)
Cesr FDA 510(k)
Cesb FDA 510(k)
Cesrb FDA 510(k)
Cest FDA 510(k)
Cestr FDA 510(k)
Cestb FDA 510(k)
Cestrb FDA 510(k)
Ces-Sb FDA 510(k)
Cesr-Sb FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4450 FDA 510(k)
Regulation Number
870.4450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Lmi Carotid Endarterectomy Shunt Catheter (#'s Ces +9 more) by Lucas Medical Inc — Class II — FDA_510K — listed in FDA 510(k) — 10 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lucas Medical Inc
FDA Applicant
Lucas Medical, Inc.

Sources (1)

  • FDA 510(k) K983802 24 fields · synced Jun 18, 2026