# K033159: Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Dec 19, 2003 after 80 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071367: Flexcel Carotid Shunt (Inlying), Model 2020-05 (2007), 0 descendants of its own

## Indications for use
Carotid Shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

Source page: https://510kreport.com/device/K033159
Methodology: https://510kreport.com/methodology