510(k) · Cleared
Recalled · 2007Triactiv FX Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corp. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Jul 11, 2006 as substantially equivalent to K042040 (Kensey Nash Corp., 2005) after an 18-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 11, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- NFA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013913 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013913 Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc. · 2002
- 1 generation backK042040 Triactiv SystemKensey Nash Corp. · 2005 · Recalled
- This deviceK061772 Triactiv FX Embolic Protection SystemKensey Nash Corp. · 2006
- Descendant · cites it directly · 0 of its ownK062870 Triactiv FX Embolic Protection System, Model PN 60040-02; -03Kensey Nash Corp. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062870Triactiv FX Embolic Protection System, Model PN 60040-02; -03Kensey Nash Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration System | Medtronic Percusurge, Inc. | 2002 | — |
| −1 | K042040 | Triactiv System | Kensey Nash Corp. | 2005 | 3 |
| 0 (this device) | K061772 | Triactiv FX Embolic Protection System | Kensey Nash Corp. | 2006 | — |
| +1 | K062870 | Triactiv FX Embolic Protection System, Model PN 60040-02; -03 | Kensey Nash Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | K042040 | Triactiv SystemSummary page 1…Class: Class 11 Device Product Code: NFA Predicate Device: Kensey Nash Corporation's TriActiv(® System (K042040) Date Prepared: June 22, 2006 Description of Device The TriActiv FX® Embolic Protection System is a temporary ba… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062870 | Triactiv FX Embolic Protection System, Model PN 60040-02; -03 | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2007 | Not classified | Z-0835-2007 | Other | Insufficient wire sealing |
| Mar 28, 2007 | Not classified | Z-0834-2007 | Other | Insufficient wire sealing |
| Mar 28, 2007 | Not classified | Z-0833-2007 | Other | Insufficient wire sealing |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K062870 (Kensey Nash Corp., 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042040.
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 TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.Om in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculafure by trapping and extracting thrombotic and atheromatous debris liberated during PCI.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061772 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061772: Triactiv FX Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061772
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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