510(k) · Cleared
Recalled · Class I · 2019Dual Lumen Embolectomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · DXE Catheter, Embolectomy
Cleared on Mar 28, 1997 after a 25-day review. The FDA summary names its predicate without a number. 2 of the 55 devices in its family, counting itself, have a Class I recall. 54 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Mar 28, 1997
- Review
- 25 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 2 (2 Class I)
- Predicates
- 0
54 later devices descend from it, 2 citing it directly. 2 of the 55 devices in this family, counting this one, have a Class I recall.
- This deviceK970762 Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997
- Descendant · cites it directly · 53 of its ownK973465 Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · Recalled (Class I)
- Descendant · 2 generations on · 51 of its ownK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- Descendant · 3 generations on · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- Descendant · 4 generations on · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K973465 Latis Graft Cleaning Cathetercites it directly · 1998
Most influential descendants
Showing 5 of 54 · See all- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · cites it directly53descendants
- K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc. · 2004 · 2 generations on51descendants
- K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · 3 generations on35descendants
- K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009 · 3 generations on7descendants
- K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970762 | Dual Lumen Embolectomy Catheter | Applied Medical Resources | 1997 | — |
| +1 | K973465 | Latis Graft Cleaning Catheter | Applied Medical Resources | 1998 | Class I |
| +2 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| +3 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +3 | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| +4 | K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | Fogarty® Thru-Lumen Embolectomy Catheter Named without a submission number | |
| * | — | Applied Medical Regular Tip Embolectomy Catheter Named without a submission number |
What descends from it? (54)
See all 542 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2019 | Class I | Z-1846-2020 | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. |
| Oct 24, 2019 | Class I | Z-1847-2020 | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K973465 (Applied Medical Resources, 1998) has gone furthest, with 53 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?
It is indicated for the removal of arterial thromboemboli, for temporary occlusion, and for infusion of fluids. It may be used with or without a guidewire.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970762: Dual Lumen Embolectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970762
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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