510(k) · Cleared
ClearedGuardwire Temporary Occlusion and Aspiration System
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 Jan 24, 2003 after a 64-day review. The FDA summary names its predicate without a number. 3 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 4 citing it directly. 3 of the 29 devices in this family, counting this one, have a Class I recall.
- This deviceK023878 Guardwire Temporary Occlusion and Aspiration SystemMedtronic Vascular · 2003
- Descendant · cites it directly · 14 of its ownK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- Descendant · 4 generations on · 10 of its ownK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K053195Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · cites it directly14descendants
- K062201Spiderx Embolic Protection DeviceEv3, Inc. · 2006 · 2 generations on13descendants
- K063785Spiderfx Embolic Protection DeviceEv3, Inc. · 2007 · 3 generations on12descendants
- K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010 · 4 generations on10descendants
- K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023878 | Guardwire Temporary Occlusion and Aspiration System | Medtronic Vascular | 2003 | — |
| +1 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +2 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| +3 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| +4 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| +1 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
| 2023 | 1 | 1 |
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 |
|---|---|---|---|
| * | — | Guardwire Temporary Occlusion and Aspiration System Named without a submission number |
What descends from it? (28)
See all 284 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 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
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K053195 (Ev3, Inc., 2006) has gone furthest, with 14 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 Guardwire 3-6 Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:
Contain and aspirate embolic material (thrombuddebris) 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/K023878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023878: Guardwire Temporary Occlusion and Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023878
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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