510(k) · Cleared
ClearedMedtronic Export AP Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DXE Catheter, Embolectomy
Cleared on Jun 27, 2008 as substantially equivalent to K061958 (Medtronic Vascular, 2006) after a 22-day review. Its family tree reaches back 4 generations to 2001. 11 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010579 (2001). 8 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 3 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 2 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 1 generation backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- This deviceK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008
- Descendant · cites it directly · 5 of its ownK120808 Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK130536 Export Advance Aspiration CatheterMedtronic, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK120508 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012
- Descendant · 3 generations on · 2 of its ownK152335 Export Advance Aspiration CatheterMedtronic, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK140296 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120808Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012 · cites it directly5descendants
- K130536Export Advance Aspiration CatheterMedtronic, Inc. · 2013 · 2 generations on4descendants
- K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012 · cites it directly3descendants
- K152335Export Advance Aspiration CatheterMedtronic, Inc. · 2015 · 3 generations on2descendants
- K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −3 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −2 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −1 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| 0 (this device) | K081573 | Medtronic Export AP Catheter | Medtronic Vascular | 2008 | — |
| +1 | K120808 | Export XT Catheter, Export AP Catheter | Medtronic, Inc. | 2012 | — |
| +2 | K130536 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2013 | — |
| +1 | K120508 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2012 | — |
| +3 | K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015 | — |
| +1 | K140296 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2014 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 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 |
|---|---|---|---|
| * | K061958 | Medtronic Export XT CatheterSummary page 5…0 [email protected] June 4™, 2008 Medtronic Export® AP Aspiration Catheter Aspiration Catheter Embolectomy Catheter Medtronic Export® XT Aspiration Catheter K061958 The Medtronic Export® AP Aspiration Catheter is a dual lumen catheter used for aspiration of thrombus and/or debris from a vascu… | 2006 |
What descends from it? (11)
See all 114 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 7 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K120808 (Medtronic, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K061958.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Medtronic Export® AP Catheter is indicated for:
* Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
* To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion
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/K081573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081573: Medtronic Export AP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081573
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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