510(k) Report

510(k) · Cleared

Cleared

Triactiv FX Embolic Protection System, Model PN 60040-02; -03

K062870510(k) SpecialCleared Oct 20, 200625-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kensey Nash Corp. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Cleared on Oct 20, 2006 as substantially equivalent to K061772 (Kensey Nash Corp., 2006) after a 25-day review. Its family tree reaches back 3 generations to 2002.

Decided
Oct 20, 2006
Review
25 days
Class
Class II
Product code
NFA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K013913 (2002). No later device cites it as a predicate yet.

K013913 · Percusurge Guardwire Plus Temporary Occlusion and Aspiration System · Medtronic Percusurge, Inc. · 2002K042040 · Triactiv System · Kensey Nash Corp. · 2005 · recalledK061772 · Triactiv FX Embolic Protection System · Kensey Nash Corp. · 2006 · recalled20002002200420062008
K061772 · Triactiv FX Embolic Protection System · Kensey Nash Corp. · 2006 · recalledK042040 · Triactiv System · Kensey Nash Corp. · 2005 · recalledK013913 · Percusurge Guardwire Plus Temporary Occlusion and Aspiration System · Medtronic Percusurge, Inc. · 20020
  1. Root · 3 generations backK013913 Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc. · 2002
  2. 2 generations backK042040 Triactiv SystemKensey Nash Corp. · 2005 · Recalled
  3. 1 generation backK061772 Triactiv FX Embolic Protection SystemKensey Nash Corp. · 2006 · Recalled
  4. This deviceK062870 Triactiv FX Embolic Protection System, Model PN 60040-02; -03Kensey Nash Corp. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K013913Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc.2002—
−2K042040Triactiv SystemKensey Nash Corp.20053
−1K061772Triactiv FX Embolic Protection SystemKensey Nash Corp.20063
0 (this device)K062870Triactiv FX Embolic Protection System, Model PN 60040-02; -03Kensey Nash Corp.2006—
FIG. 1 — Lineage of K062870, 2002–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K061772Triactiv FX Embolic Protection System
Summary page 1
…Class 11 Device Product Code: NFA Predicate Device: Kensey Nash Corporation's TriActiv FX® System (K061 772) Date Prepared: September 21, 2006 Description of Device The TriActiv FX® Embolic Protection System is a temp…
Kensey Nash Corp.20063

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 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 2 of the 3 ancestors have a recall of any class.

How does its category compare?

All NFA devices

NFA 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

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

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

2007: 1102008: 802009: 1042010: 1832011: 452012: 552013: 482014: 422015: 412016: 632017: 502018: 782019: 402020: 202021: 252022: 232023: 222024: 552025: 91
2007high 183 (2010) · low 20 (2020)2025

MAUDE reports naming product code NFA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0110
20082—080
20090—0104
20100—0183
20110—045
20120—055
20130—048
20140—042
20150—041
20160—063
20170—050
20180—078
20190—040
20200—020
20210—025
20220—023
20230—022
20240—055
20250—091
20260—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 vasculature 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.

More from Kensey Nash Corp.

19 FDA decisions under this applicant name. See the company

  • K103787Medeor MatrixKensey Nash Corp. · 2011
  • K091192Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXKensey Nash Corp. · 2009
  • K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
  • K090919Kensey Nash Fibrillar Collagen Dental MembraneKensey Nash Corp. · 20093 recalls
  • K073519Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp. · 20081 recall

Recent decisions in NFA

The NFA category page

  • K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc. · 2008
  • K073563Modification to Proxis SystemSt Jude Medical · 2008
  • K063785Spiderfx Embolic Protection DeviceEv3, Inc. · 2007
  • K060651Proxis System, Model EPS101St Jude Medical · 2006
  • K052523Proxis SystemVelocimed, Inc. · 2006

https://510kreport.com/device/K062870 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062870: Triactiv FX Embolic Protection System, Model PN 60040-02; -03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062870

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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