510(k) · Cleared

Cleared

Modification to Guardwire Plus Temporary Occlusion & Aspiration System

K014223510(k) SpecialCleared Jan 25, 200230-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

Medtronic Percusurge, Inc. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Cleared on Jan 25, 2002 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 99 devices in its family, counting itself, have a Class I recall. 98 later devices descend from it.

Decided: Jan 25, 2002
Review: 30 days
Class: Class II
Product code: NFA
Recalls: None
Predicates: 0

98 later devices descend from it, 2 citing it directly. 3 of the 99 devices in this family, counting this one, have a Class I recall.

This deviceK014223 Modification to Guardwire Plus Temporary Occlusion & 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 · cites it directly · 48 of its ownK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
Descendant · 2 generations on · 35 of its ownK032884 Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval…Boston Scientific Epi · 2004
Descendant · 3 generations on · 30 of its ownK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2003high 13 (2006) · low 0 (2024)2026

Class I recalls in this family

K153485 ENROUTE Transcarotid Neuroprotection System5 generations on · 2016
K230402 ENROUTE® Transcarotid Neuroprotection System6 generations on · 2023
K210282 WIRION Embolic Protection System7 generations on · 2021

Most influential descendants

Showing 5 of 98 · See all

K030201Modification to Export Aspiration CatheterMedtronic Vascular · 2003 · cites it directly60descendants
K040869Export CatheterMedtronic Vascular · 2004 · 2 generations on59descendants
K023691Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003 · cites it directly48descendants
K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi · 2004 · 2 generations on35descendants
K061958Medtronic Export XT CatheterMedtronic Vascular · 2006 · 3 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K014223	Modification to Guardwire Plus Temporary Occlusion & Aspiration System	Medtronic Percusurge, Inc.	2002	—
+1	K030201	Modification to Export Aspiration Catheter	Medtronic Vascular	2003	—
+2	K040869	Export Catheter	Medtronic Vascular	2004	—
+1	K023691	Boston Scientific Filterwire EX Embolic	Boston Scientific Epi	2003	—
+2	K032884	Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath	Boston Scientific Epi	2004	—
+3	K061958	Medtronic Export XT Catheter	Medtronic Vascular	2006	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	3	0
2005	6	0
2006	13	0
2007	8	0
2008	10	0
2009	5	0
2010	2	0
2011	5	0
2012	7	0
2013	3	0
2014	1	0
2015	4	0
2016	3	1
2017	6	0
2018	5	0
2019	1	0
2020	4	0
2021	2	1
2022	2	0
2023	3	1
2025	1	0
2026	2	0

FIG. 1 — Lineage of K014223, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (98)

See all 98

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030201	Modification to Export Aspiration Catheter	Medtronic Vascular	2003	60
K023691	Boston Scientific Filterwire EX Embolic	Boston Scientific Epi	2003	48

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 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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	110
2008	2	—	80
2009	0	—	104
2010	0	—	183
2011	0	—	45
2012	0	—	55
2013	0	—	48
2014	0	—	42
2015	0	—	41
2016	0	—	63
2017	0	—	50
2018	0	—	78
2019	0	—	40
2020	0	—	20
2021	0	—	25
2022	0	—	23
2023	0	—	22
2024	0	—	55
2025	0	—	91
2026	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 to:

Contain and aspirate embolic material (thrombus/debris) 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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014223 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014223: Modification to Guardwire Plus Temporary Occlusion & 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/K014223

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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