510(k) · Cleared
ClearedPercusurge Guardwire Plus Temporary Occlusion and Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Percusurge, Inc. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Nov 15, 2002 after a 353-day review. The FDA summary names its predicate without a number. 3 of the 75 devices in its family, counting itself, have a Class I recall. 74 later devices descend from it.
- Decided
- Nov 15, 2002
- Review
- 353 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 0
74 later devices descend from it, 6 citing it directly. 3 of the 75 devices in this family, counting this one, have a Class I recall.
- This deviceK013913 Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc. · 2002
- Descendant · cites it directly · 60 of its ownK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- Descendant · 2 generations on · 59 of its ownK040869 Export CatheterMedtronic Vascular · 2004
- Descendant · 3 generations on · 30 of its ownK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- Descendant · 3 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- Descendant · 3 generations on · 14 of its ownK050139 Modification to: Export CatheterMedtronic Vascular · 2005
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 74 · See all- K030201Modification to Export Aspiration CatheterMedtronic Vascular · 2003 · cites it directly60descendants
- K040869Export CatheterMedtronic Vascular · 2004 · 2 generations on59descendants
- K061958Medtronic Export XT CatheterMedtronic Vascular · 2006 · 3 generations on30descendants
- K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 3 generations on16descendants
- K050139Modification to: Export CatheterMedtronic Vascular · 2005 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration System | Medtronic Percusurge, Inc. | 2002 | — |
| +1 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| +2 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| +3 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| +3 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| +3 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 1 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 1 |
| 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.
3 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? (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 |
|---|---|---|---|
| * | — | 3-6 Guardwire Plus System Named without a submission number |
What descends from it? (74)
See all 746 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030201 | Modification to Export Aspiration Catheter | 2003 | 60 |
| K051984 | Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300 | 2006 | 7 |
| K042040 | Triactiv System | 2005 | 6 |
| K060651 | Proxis System, Model EPS101 | 2006 | 3 |
| K052523 | Proxis System | 2006 | 2 |
| K073523 | Interceptor Plus Coronary Filter Systems | 2008 | 0 |
Has anything in its family been recalled? (3 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 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K030201 (Medtronic Vascular, 2003) has gone furthest, with 60 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 PercuSurge Guardwire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.Omm) to: Contain and aspirate embolic material (thrombusldebris) 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 the device as an embolic…
Read the full statement (115 words)
The PercuSurge Guardwire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.Omm) to:
Contain and aspirate embolic material (thrombusldebris) 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 the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013913 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013913
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026