# K983802: Lmi Carotid Endarterectomy Shunt Catheter, Model #'S Ces, Cesr, Cesb, Cesrb, Cest, Cestr, Cestb, Cestrb, Ces-SB, Cesr-SB

- Pathway: 510(k) (Traditional)
- Applicant: Lucas Medical, Inc.
- Decided: Jul 30, 1999 after 275 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vascushunt Carotid Silicone Catheter: named in the summary without a submission number
- (no number) Pruit-Inahara Carotid Shunt: named in the summary without a submission number
- (no number) Sundt Internal and External Carotid Shunts: named in the summary without a submission number

## Indications for use
The LMI Carotid Endarterectomy Shunt Catheter is intended for use during a carotid endarterectomy procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation.

Source page: https://510kreport.com/device/K983802
Methodology: https://510kreport.com/methodology