# K051067: Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)

- Pathway: 510(k) (Special)
- Applicant: LeMaitre Vascular, Inc.
- Decided: May 27, 2005 after 31 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: 2 generations back to K960715 (1996). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043023: Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49, LeMaitre Vascular, Inc. (2004) Summary page 1.

## Most influential descendants
- K143454: Pruitt F3-S Carotid Shunt (2015), 1 descendant of its own
- K182916: Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr (2018), 0 descendants of its own
- K152833: Pruitt F3-S Polyurethane Carotid Shunt (2016), 0 descendants of its own
- K103356: Pruitt Carotid Kit (2010), 0 descendants of its own
- K071367: Flexcel Carotid Shunt (Inlying), Model 2020-05 (2007), 0 descendants of its own

## Recalls of this device
- Oct 4, 2011 · Not classified · Z-0070-2012: Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05

## Indications for use
1. The Pruitt-lnahara ®, Inahara-Pruir and Pruit F3 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. 2. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.

Source page: https://510kreport.com/device/K051067
Methodology: https://510kreport.com/methodology