# K143454: Pruitt F3-S Carotid Shunt

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Aug 27, 2015 after 267 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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) Summary page 4.

## Most influential descendants
- K152833: Pruitt F3-S Polyurethane Carotid Shunt (2016), 0 descendants of its own

## Indications for use
The Pruitt F3-S Carotid Shunt is 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/K143454
Methodology: https://510kreport.com/methodology