510(k) · Cleared
ClearedModification to Export Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Mar 26, 2003 as substantially equivalent to K023303 (Medtronic Vascular, 2002) and 3 other predicates after a 64-day review. Its family tree reaches back 1 generation to 2001. 2 of the 65 devices in its family, counting itself, have a Class I recall. 60 later devices descend from it.
- Decided
- Mar 26, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K010579 (2001). 4 ancestors in all. 60 later devices descend from it, 2 citing it directly. 2 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- This deviceK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- Descendant · cites it directly · 59 of its ownK040869 Export CatheterMedtronic Vascular · 2004
- Descendant · 2 generations on · 30 of its ownK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- Descendant · 2 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- Descendant · 2 generations on · 14 of its ownK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- Descendant · 2 generations on · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 60 · See all- K040869Export CatheterMedtronic Vascular · 2004 · cites it directly59descendants
- K061958Medtronic Export XT CatheterMedtronic Vascular · 2006 · 2 generations on30descendants
- K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 2 generations on16descendants
- K050139Modification to: Export CatheterMedtronic Vascular · 2005 · 2 generations on14descendants
- K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| 0 (this device) | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| +1 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| +2 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| +2 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| +2 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| +2 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 1 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K023303 | Export Aspiration Catheter | 2002 |
| * | K014223 | Modification to Guardwire Plus Temporary Occlusion & Aspiration SystemSummary page 7…hed in treating native coronaries. When the proposed device is included in the Guardwire 3-6 Temporary Occlusion and Aspiration System (cleared under KO03992 and K014223) the indications for that system will not change. This system will be labeled as shown below: h.. The PercuSurge Guardwir… | 2002 |
| * | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration System | 2002 |
| * | K010579 | Stent Support Guide Catheter | 2001 |
What descends from it? (60)
See all 602 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)
No FDA recall names this device.
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.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K040869 (Medtronic Vascular, 2004) has gone furthest, with 59 descendants of its own.
How does its category compare?
All NFA devicesNFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFA
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NFA
Too few NFA 510(k)s in any year since 2007 to give a median.
Recalls per year · NFA
No recall names NFA since 2007.
Adverse event reports per year · NFA
91in 2025
MAUDE reports naming product code NFA, 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 | 1 | — | 0 | 110 |
| 2008 | 2 | — | 0 | 80 |
| 2009 | 0 | — | 0 | 104 |
| 2010 | 0 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 55 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 42 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 50 |
| 2018 | 0 | — | 0 | 78 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 55 |
| 2025 | 0 | — | 0 | 91 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indication for use for the stand-alone Export Catheter is: The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to: Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures. To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel…
Read the full statement (338 words)
The indication for use for the stand-alone Export Catheter is:
The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:
Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
When the proposed modified device is included in the Guardwire 2.5-5 Temporary Occlusion and Aspiration System cleared under K013913 the indications for that system will not change. This system will be labeled as shown below:
The PercuSurge Guardwire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:
Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
When the proposed device is included in the Guardwire 3-6 Temporary Occlusion and Aspiration System (cleared under K003992 and K014223) the indications for that system will not change. This system will be labeled as shown below:
The PercuSurge Guardwire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:
Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030201: Modification to Export Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030201
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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