510(k) · Cleared
Recalled · Class I · 2019Latis Graft Cleaning 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 Feb 19, 1998 as substantially equivalent to K910372 (Applied Vascular Devices, Inc., 1991) and 2 other predicates after a 160-day review. Its family tree reaches back 1 generation to 1991. 2 of the 57 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Feb 19, 1998
- Review
- 160 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910372 (1991). 3 ancestors in all. 53 later devices descend from it, 2 citing it directly. 2 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK910372 Intimax Thrombectomy CatheterApplied Vascular Devices, Inc. · 1991 · Recalled
- This deviceK973465 Latis Graft Cleaning CatheterApplied Medical Resources · 1998
- Descendant · cites it directly · 51 of its ownK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- Descendant · 2 generations on · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970762 Dual Lumen Embolectomy Catheterdirect predicate · 1997
Most influential descendants
Showing 5 of 53 · See all- K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc. · 2004 · cites it directly51descendants
- K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · 2 generations on35descendants
- K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009 · 2 generations on7descendants
- K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · 3 generations on6descendants
- K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910372 | Intimax Thrombectomy Catheter | Applied Vascular Devices, Inc. | 1991 | 1 |
| 0 (this device) | K973465 | Latis Graft Cleaning Catheter | Applied Medical Resources | 1998 | — |
| +1 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| +2 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +2 | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| +3 | K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017 | — |
| +3 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K910372 | Intimax Thrombectomy CatheterSummary page 1…ional safety, structural integrity and material safety. All testing demonstrated that the Applied Medical Graft Cleaning Catheter is comparable to the predicate devices (K910372, K950586, K970762) and introduces no new safety and effectiveness issues when used as indicated. 33 LRVIC, g SEE… | 1991 |
| * | K950586 | Avd Intimax Thrombectomy CatheterSummary page 1…ety, structural integrity and material safety. All testing demonstrated that the Applied Medical Graft Cleaning Catheter is comparable to the predicate devices (K910372, K950586, K970762) and introduces no new safety and effectiveness issues when used as indicated. 33 LRVIC, g SEES 5 NEAL… | 1995 |
| * | K970762 | Dual Lumen Embolectomy CatheterSummary page 1…ctural integrity and material safety. All testing demonstrated that the Applied Medical Graft Cleaning Catheter is comparable to the predicate devices (K910372, K950586, K970762) and introduces no new safety and effectiveness issues when used as indicated. 33 LRVIC, g SEES 5 NEALTH o 4,… | 1997 |
What descends from it? (53)
See all 532 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-1848-2020 | 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.
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K040010 (Genesis Medical Interventional, Inc., 2004) has gone furthest, with 51 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 Applied Medical /atis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.
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/K973465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973465: Latis Graft Cleaning Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973465
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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