# K152833: Pruitt F3-S Polyurethane Carotid Shunt

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Jan 21, 2016 after 114 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 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)
- K143454: Pruitt F3-S Carotid Shunt, LeMaitre Vascular, Inc. (2015) Summary page 4.

## Recalls of this device
- Oct 1, 2018 · Class II · Z-0473-2019: Pouches from this lot are not sealed compromising the sterility

## Indications for use
The Pruitt F3-S Polyurethane Carotid Shunt is intended 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/K152833
Methodology: https://510kreport.com/methodology