510(k) · Cleared

Cleared

Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

K033159510(k) TraditionalCleared Dec 19, 200380-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

LeMaitre Vascular, Inc. · MJN Catheter, Intravascular Occluding, Temporary

Cleared on Dec 19, 2003 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Dec 19, 2003
Review: 80 days
Class: Class II
Product code: MJN
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK033159 Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05…LeMaitre Vascular, Inc. · 2003
Descendant · cites it directly · 0 of its ownK071367 Flexcel Carotid Shunt (Inlying), Model 2020-05LeMaitre Vascular, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K071367Flexcel Carotid Shunt (Inlying), Model 2020-05LeMaitre Vascular, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K033159	Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01…	LeMaitre Vascular, Inc.	2003	—
+1	K071367	Flexcel Carotid Shunt (Inlying), Model 2020-05	LeMaitre Vascular, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K033159, 2003–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MJN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MJN device

#1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071367	Flexcel Carotid Shunt (Inlying), Model 2020-05	LeMaitre Vascular, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K071367 (LeMaitre Vascular, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MJN devices

MJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJN

2in 2025

2007high 5 (2009) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJN

116in 2021

2007high 245 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MJN

1in 2020

2007high 8 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJN

194in 2025

2007high 224 (2024) · low 25 (2007)2025

MAUDE reports naming product code MJN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	25
2008	3	153	2	26
2009	5	39	0	25
2010	5	30	1	35
2011	4	69	1	92
2012	2	—	0	53
2013	4	87	8	76
2014	2	—	0	100
2015	4	245	1	90
2016	3	110	2	71
2017	3	54	0	157
2018	3	63	1	107
2019	3	117	0	139
2020	4	64	1	157
2021	4	116	0	158
2022	2	—	0	148
2023	1	—	0	181
2024	0	—	0	224
2025	2	—	0	194
2026	0	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K033159 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033159: Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033159

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026