510(k) · Cleared
ClearedLemaitre Venous Thrombectomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascutech, Inc. · DXE Catheter, Embolectomy
Cleared on Mar 1, 2000 after a 183-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Mar 1, 2000
- Review
- 183 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK992934 Lemaitre Venous Thrombectomy CatheterVascutech, Inc. · 2000
- Descendant · cites it directly · 10 of its ownK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
- Descendant · 4 generations on · 4 of its ownK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
- Descendant · 5 generations on · 3 of its ownK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K070403Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly10descendants
- K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011 · 2 generations on6descendants
- K192814Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020 · 3 generations on5descendants
- K211492Pounce Thrombectomy SystemSurmodics,Inc. · 2021 · 4 generations on4descendants
- K220501Pounce Thrombectomy SystemSurmodics,Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992934 | Lemaitre Venous Thrombectomy Catheter | Vascutech, Inc. | 2000 | — |
| +1 | K070403 | Pronto .035 Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +2 | K110315 | Nexgen Peripheral Mechanical Retrieval Device | Nexgen Medical Systems, Inc. | 2011 | — |
| +3 | K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020 | — |
| +4 | K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021 | — |
| +5 | K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070403 | Pronto .035 Extraction Catheter | 2007 | 10 |
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, K070403 (Vascular Solutions, Inc., 2007) has gone furthest, with 10 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 Venous Thrombectomy Catheter is indicated for the removal of venous thrombi.
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/K992934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992934: Lemaitre Venous Thrombectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992934
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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