510(k) · Cleared
ClearedInterceptor Plus Coronary Filter Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Aug 1, 2008 as substantially equivalent to K061332 (Boston Scientific Corp, 2006) and 4 other predicates after a 231-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Aug 1, 2008
- Review
- 231 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K003992 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 5 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 4 generations backK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
- 3 generations backK053195 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 2 generations backK062201 Spiderx Embolic Protection DeviceEv3, Inc. · 2006
- 1 generation backK063785 Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
- This deviceK073523 Interceptor Plus Coronary Filter SystemsMedtronic, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −5 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −4 | K032884 | Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath | Boston Scientific Epi | 2004 | — |
| −3 | K053195 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −2 | K062201 | Spiderx Embolic Protection Device | Ev3, Inc. | 2006 | — |
| −1 | K063785 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2007 | — |
| 0 (this device) | K073523 | Interceptor Plus Coronary Filter Systems | Medtronic, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
Planning a device in NFA? 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? (5)
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 |
|---|---|---|---|
| * | K061332 | Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Summary page 1…ietary Name: Interceptor® PLUS Coronary Filter System 4. Name of Predicate Devices: FilterWire EZTm Embolic Protection System (2.25mm-3.5mm) K06 1332 FilterWire EZTm Embolic Protection System K052280 SpiderFX T m Embolic Protection Device… | 2006 |
| * | K052280 | Filterwire EZ Embolic Protection SystemSummary page 1…ate Devices: FilterWire EZTm Embolic Protection System (2.25mm-3.5mm) K06 1332 FilterWire EZTm Embolic Protection System K052280 SpiderFX T m Embolic Protection Device K063 785 PercuSurge Guard Wire Temporary Occlus… | 2005 |
| * | K063785 | Spiderfx Embolic Protection DeviceSummary page 1…K06 1332 FilterWire EZTm Embolic Protection System K052280 SpiderFX T m Embolic Protection Device K063 785 PercuSurge Guard Wire Temporary Occlusion and Aspiration System… | 2007 |
| * | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemSummary page 1…K063 785 PercuSurge Guard Wire Temporary Occlusion and Aspiration System K013913 Guard Wire 3-6 Temporary Occlusion and Aspiration System K023878… | 2002 |
| * | K023878 | Guardwire Temporary Occlusion and Aspiration SystemSummary page 1…Aspiration System K013913 Guard Wire 3-6 Temporary Occlusion and Aspiration System K023878 155 5. Description:… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K061332.
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. 2008, this device’s year, is highlighted.
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 Medtronic Interceptor® PLUS Coronary Filter System is intended for use in saphenous vein bypass grafts, with a reference vessel diameter between 2.5 mm and 5.25mm, in conjunction with percutaneous transluminal coronary intervention (PTCI) for embolic particulate capture. The Interceptor® PLUS Coronary Filter System is intended for temporary use in conjunction with other therapeutic devices and is intended to be removed at the completion of the interventional procedure.
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/K073523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073523: Interceptor Plus Coronary Filter Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073523
Report an extraction error
Are you the manufacturer?
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