510(k) · Cleared
ClearedExport Advance Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DXE Catheter, Embolectomy
Cleared on Sep 18, 2015 as substantially equivalent to K130536 (Medtronic, Inc., 2013) after a 30-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 18, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010579 (2001). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 6 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 5 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 4 generations backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- 3 generations backK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008
- 2 generations backK120808 Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012
- 1 generation backK130536 Export Advance Aspiration CatheterMedtronic, Inc. · 2013
- This deviceK152335 Export Advance Aspiration CatheterMedtronic, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK253589 Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK190619 Aspiron (TM) Aspiration CatheterMeril Life Sciences Private Limited · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −6 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −5 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −4 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| −3 | K081573 | Medtronic Export AP Catheter | Medtronic Vascular | 2008 | — |
| −2 | K120808 | Export XT Catheter, Export AP Catheter | Medtronic, Inc. | 2012 | — |
| −1 | K130536 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2013 | — |
| 0 (this device) | K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015 | — |
| +1 | K253589 | Liberant™ RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | 2026 | — |
| +1 | K190619 | Aspiron (TM) Aspiration Catheter | Meril Life Sciences Private Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K130536 | Export Advance Aspiration CatheterSummary page 4…Percutaneous Catheter Classification Name: Embolectomy Catheter Class II per 21 CFR 870.5150, Product Code DXE Predicate Devices: K130536 - Medtronic Vascular Export® Advance Aspiration Catheter. Device The Export Advance™… | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K253589 (Medtronic Interventional Vascular, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K130536.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Export Advance™ Aspiration Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152335: Export Advance Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152335
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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