510(k) · Cleared

Cleared

Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire

K140695510(k) TraditionalCleared Jun 12, 201485-day reviewClass II21 CFR 870.1330

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

Medtronic, Inc. · DQX Wire, Guide, Catheter

Cleared on Jun 12, 2014 as substantially equivalent to K091582 (Medtronic Vascular, 2009) and 4 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1997. 5 of the 8 devices in its family, counting itself, have a Class I recall.

Decided: Jun 12, 2014
Review: 85 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K970466 (1997). 7 ancestors in all. No later device cites it as a predicate yet. 5 of the 8 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK970466 Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · Recalled (Class I)
2 generations backK091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · Recalled (Class I)
1 generation backK100470 GTX 12 GidewireMedtronic, Inc. · 2010 · Recalled (Class I)
This deviceK140695 Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia…Medtronic, Inc. · 2014

Class I recalls in this family

K100470 GTX 12 Gidewiredirect predicate · 2010
K091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15direct predicate · 2009
K032899 Radius Cougar Wiredirect predicate · 2003
K983927 GT1 Floppy, GT1 HI-Per Flex, GT1 Light Supportdirect predicate · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K970466	Radius Ptca Guidewire	Radius Medical Technologies, Inc.	1997	Class I
−2	K091582	GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15	Medtronic Vascular	2009	Class I
−1	K100470	GTX 12 Gidewire	Medtronic, Inc.	2010	Class I
0 (this device)	K140695	Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire…	Medtronic, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	1
2000	1	0
2001	1	0
2003	1	1

FIG. 1 — Lineage of K140695, 1997–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

5 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.

Top candidate predicates for a new DQX device

#1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K091582	GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 Summary page 1 …Device: The following commercialized Medtronic PTCA Guidewires were used as predicate devices in the 510(k) submission: 1) K091582 (ProVia 3, 6, 9 and Intuition) 2) K100470 (ProVia 12) 3) K970466 (Thunder)…	Medtronic Vascular	2009	Class I
*	K100470	GTX 12 Gidewire Summary page 1 …were used as predicate devices in the 510(k) submission: 1) K091582 (ProVia 3, 6, 9 and Intuition) 2) K100470 (ProVia 12) 3) K970466 (Thunder) 4) K983927 (Zinger) 5) K032…	Medtronic, Inc.	2010	Class I
*	K970466	Radius Ptca Guidewire Summary page 1 …vices in the 510(k) submission: 1) K091582 (ProVia 3, 6, 9 and Intuition) 2) K100470 (ProVia 12) 3) K970466 (Thunder) 4) K983927 (Zinger) 5) K032899 (Cougar) Device Medtronic PT…	Radius Medical Technologies, Inc.	1997	Class I
*	K983927	GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support Summary page 1 …1) K091582 (ProVia 3, 6, 9 and Intuition) 2) K100470 (ProVia 12) 3) K970466 (Thunder) 4) K983927 (Zinger) 5) K032899 (Cougar) Device Medtronic PTCA Guidewires are steerable guidewires that…	Arterial Vascular Engineering, Inc.	1999	Class I
*	K032899	Radius Cougar Wire Summary page 1 …Intuition) 2) K100470 (ProVia 12) 3) K970466 (Thunder) 4) K983927 (Zinger) 5) K032899 (Cougar) Device Medtronic PTCA Guidewires are steerable guidewires that are Description: used during the Per…	Radius Medical Technologies, Inc.	2003	Class I

Also cleared against K091582: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (5 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.

K100470GTX 12 GidewireMedtronic, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K032899Radius Cougar WireRadius Medical Technologies, Inc. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
K983927GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 12 Class I recalls
K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
5 of the 7 ancestors have a recall of any class; 5 have a Class I recall.
2 other devices also cite its predicate K091582.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

Medtronic Pro ViaTm and IntuitionTM Guidewires: Medtronic [Pro ViaTM and JntuitionTM] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the…

Read the full statement (184 words)

Medtronic Pro ViaTm and IntuitionTM Guidewires:

Medtronic [Pro ViaTM and JntuitionTM] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

ThunderM Guidewires:

Medtronic [ThunderM] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.

ZingeTm Guidewires:

Medtronic [ZingerTM] guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. [ZingerTM] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

CougarTrmCuidewires:

Medtronic CougarTM wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140695 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140695: Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140695

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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