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Carotid Endarterectomy Shunt

FDA UDI

Class II (US FDA UDI)

by Lucas Medical Inc

Identity

Trade Name
CAROTID ENDARTERECTOMY SHUNT FDA UDI
Generic Name
Carotid artery shunt FDA UDI
Model / Reference
8FCES15 FDA UDI

Identifiers

Primary DI / UDI-DI
B3808FCES150 FDA UDI
510(k) Number
K983802 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Carotid artery shunt FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Carotid artery shunt

Carotid Endarterectomy Shunt by Lucas Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carotid artery shunt.

Cleared under the same submission

K983802 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lucas Medical Inc

Sources (1)

  • FDA UDI 30288ae7-58b6-4204-b4db-9258b315de49 33 fields · synced Jun 1, 2026