510(k) · Cleared

Cleared

Modification to HI-Torque Whisper Guidewire

K030019510(k) SpecialCleared Jan 24, 200321-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

Guidant Corp. · DQX Wire, Guide, Catheter

Cleared on Jan 24, 2003 as substantially equivalent to K020340 (Guidant Corp., 2002) after a 21-day review. Its family tree reaches back 3 generations to 2000. 1 of the 14 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.

Decided: Jan 24, 2003
Review: 21 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K002206 (2000). 10 later devices descend from it, 4 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
2 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
1 generation backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
This deviceK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
Descendant · cites it directly · 3 of its ownK083094 Streamer Polymer GuidewireBrivant, Ltd. · 2009
Descendant · cites it directly · 3 of its ownK061453 HI-Torque Whisper View Guide WireGuidant Corp. · 2006
Descendant · 2 generations on · 2 of its ownK103377 Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011
Descendant · 2 generations on · 1 of its ownK090554 Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009
Descendant · cites it directly · 1 of its ownK063210 Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478…Medtronic Inc. Cardiac Rhythm Management · 2007 · Recalled (Class I)

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 2 (2009) · low 0 (2010)2026

Class I recalls in this family

K063210 Attain Hybrid Guide Wires, Model GWR419378…cites it directly · 2007

Most influential descendants

Showing 5 of 10 · See all

K083094Streamer Polymer GuidewireBrivant, Ltd. · 2009 · cites it directly3descendants
K061453HI-Torque Whisper View Guide WireGuidant Corp. · 2006 · cites it directly3descendants
K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011 · 2 generations on2descendants
K090554Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009 · 2 generations on1descendant
K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidant Corp.	2000	—
−2	K013092	HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating	Guidant Corp.	2001	—
−1	K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat…	Guidant Corp.	2002	—
0 (this device)	K030019	Modification to HI-Torque Whisper Guidewire	Guidant Corp.	2003	—
+1	K083094	Streamer Polymer Guidewire	Brivant, Ltd.	2009	—
+1	K061453	HI-Torque Whisper View Guide Wire	Guidant Corp.	2006	—
+2	K103377	Charter Guidewire Model 45-281, 45-282, 45-283	Brivant, Ltd.	2011	—
+2	K090554	Acuity Mailman and Strait-Trak Guidewire	Boston Scientific Corp	2009	—
+1	K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488	Medtronic Inc. Cardiac Rhythm Management	2007	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	1
2008	1	0
2009	2	0
2011	2	0
2012	1	0
2014	1	0
2015	1	0

FIG. 1 — Lineage of K030019, 2000–2015Source: 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.

1 device in this family has 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

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What was it cleared against? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating Summary page 2 …CS-J, DS/DS CS-J, and EDSEDS CS-J Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER Guide Wires (K020340March 1,2002, and K02128YMay 2,2002). Device Description: The general guide wire design consists of a stainless steel tapered cor…	Guidant Corp.	2002	—
Kept off the family tree	K021287	FDA’s K021287 is Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Medtronic Perfusion Systems	2002	1

Also cleared against K020340: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K083094	Streamer Polymer Guidewire	Brivant, Ltd.	2009	3
K061453	HI-Torque Whisper View Guide Wire	Guidant Corp.	2006	3
K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 Class I	Medtronic Inc. Cardiac Rhythm Management	2007	1
K082935	Vision Wire Coronary Guidewire	Biotronik, Inc.	2008	0

Has anything in its family been recalled? (1 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.

K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 11 months on median.
None of the 3 ancestors has a recall.
Of its descendants, K083094 (Brivant, Ltd., 2009) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K020340.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030019: Modification to HI-Torque Whisper Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030019

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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