# K103356: Pruitt Carotid Kit

- Pathway: 510(k) (Special)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Dec 8, 2010 after 22 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: 4 generations back to K842066 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has 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)
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16, Pm Devices, Inc. (2004) Summary page 1.

## Indications for use
For Pruitt F3 Carotid Shunts: The Pruitt 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. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt. For XenoSure Biologic Patch: The patch is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

Source page: https://510kreport.com/device/K103356
Methodology: https://510kreport.com/methodology