510(k) · Cleared
ClearedFlexcel Carotid Shunt (Inlying), Model 2020-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Aug 29, 2007 as substantially equivalent to K051067 (LeMaitre Vascular, Inc., 2005) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 29, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960715 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960715 Pruitt-Inahara Carotid Shunt 400-40-8F/Inahara-Pruitt Carotid Shunt…Ideas For Medicine, Inc. · 1996
- 2 generations backK043023 Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49…LeMaitre Vascular, Inc. · 2004
- 1 generation backK051067 Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)LeMaitre Vascular, Inc. · 2005 · Recalled
- This deviceK071367 Flexcel Carotid Shunt (Inlying), Model 2020-05LeMaitre Vascular, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960715 | Pruitt-Inahara Carotid Shunt 400-40-8F/Inahara-Pruitt Carotid Shunt 500-50-8F | Ideas For Medicine, Inc. | 1996 | — |
| −2 | K043023 | Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49… | LeMaitre Vascular, Inc. | 2004 | — |
| −1 | K051067 | Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port) | LeMaitre Vascular, Inc. | 2005 | 1 |
| 0 (this device) | K071367 | Flexcel Carotid Shunt (Inlying), Model 2020-05 | LeMaitre Vascular, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051067 | Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port) | 2005 |
| * | K033159 | Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05…Summary page 1…antially equivalent with regard to these features in the predicate device, the Pruitt F3 Carotid Shunt (KO51067) and LeMaitre Vascular Straight Carotid Shunt (K033159) Device Description: The FlexcelTM Carotid Shunt is designed to serve as a temporary blood conduit connect… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K051067.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 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 summary.
https://510kreport.com/device/K071367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071367: Flexcel Carotid Shunt (Inlying), Model 2020-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071367
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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