510(k) · Cleared
ClearedFogarty Occlusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jan 21, 2010 after a 30-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 21, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK093911 Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2010
- Descendant · cites it directly · 2 of its ownK152762 Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK211610 Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2022
- Descendant · cites it directly · 0 of its ownK160598 REBOA Balloon CatheterNuMED, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK132022 Lemaitre 8F Occlusion CatheterLeMaitre Vascular, Inc. · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K152762Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2015 · cites it directly2descendants
- K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2022 · 2 generations on0descendants
- K160598REBOA Balloon CatheterNuMED, Inc. · 2016 · cites it directly0descendants
- K132022Lemaitre 8F Occlusion CatheterLeMaitre Vascular, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093911 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2010 | — |
| +1 | K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2015 | — |
| +2 | K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2022 | — |
| +1 | K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016 | — |
| +1 | K132022 | Lemaitre 8F Occlusion Catheter | LeMaitre Vascular, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | — | Fogarty Occlusion Catheter, Pre-amendment Device Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K152762 (Edwards Lifesciences, LLC, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Fogarty Occlusion Catheter is indicated for temporary vessel occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093911 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093911: Fogarty Occlusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093911
Report an extraction error
Are you the manufacturer?
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