# K071367: Flexcel Carotid Shunt (Inlying), Model 2020-05

- Pathway: 510(k) (Special)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Aug 29, 2007 after 105 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
Longest line of descent: 3 generations back to K960715 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051067: Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port), LeMaitre Vascular, Inc. (2005)
- K033159: Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05, LeMaitre Vascular, Inc. (2003) Summary page 1.

## 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/K071367
Methodology: https://510kreport.com/methodology