# K182916: Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

- Pathway: 510(k) (Special)
- Applicant: Lemaitre Vascular
- Decided: Nov 16, 2018 after 29 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Pruitt F3 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/K182916
Methodology: https://510kreport.com/methodology