510(k) · Cleared
ClearedLemaitre Balloon Catheter with Irrigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascutech, Inc. · DXE Catheter, Embolectomy
Cleared on Feb 22, 2000 after a 175-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Feb 22, 2000
- Review
- 175 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK992940 Lemaitre Balloon Catheter with IrrigationVascutech, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK041517 InfusioncathId, LLC · 2004
- Descendant · 2 generations on · 1 of its ownK052738 Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016…Veinrx, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK073400 Varicath Peripheral Infusion CatheterVeinrx, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK052844 Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG · 2006
Most influential descendants
Showing 4 of 4 · See all- K041517InfusioncathId, LLC · 2004 · cites it directly3descendants
- K052738Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028…Veinrx, Inc. · 2005 · 2 generations on1descendant
- K073400Varicath Peripheral Infusion CatheterVeinrx, Inc. · 2007 · 2 generations on0descendants
- K052844Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992940 | Lemaitre Balloon Catheter with Irrigation | Vascutech, Inc. | 2000 | — |
| +1 | K041517 | Infusioncath | Id, LLC | 2004 | — |
| +2 | K052738 | Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024… | Veinrx, Inc. | 2005 | — |
| +2 | K073400 | Varicath Peripheral Infusion Catheter | Veinrx, Inc. | 2007 | — |
| +2 | K052844 | Kavs - Catheter, Models 1107100 & 1107060 | Richter & Rothe AG | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041517 | Infusioncath | 2004 | 3 |
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, K041517 (Id, LLC, 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The LeMaitre Balloon Catheter with Irrigation is indicated for the extraction of emboli and thrombi from the peripheral arterial system and also may be used for infusion of fluids.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992940: Lemaitre Balloon Catheter with Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992940
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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