510(k) · Cleared

Recalled · Class I · 2013

Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488

K063210510(k) TraditionalCleared Mar 15, 2007143-day reviewClass II21 CFR 870.1330Recalls 1 (1 Class I)

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

Medtronic Inc. Cardiac Rhythm Management · DQX Wire, Guide, Catheter

Cleared on Mar 15, 2007 as substantially equivalent to K030019 (Guidant Corp., 2003) and 3 other predicates after a 143-day review. Its family tree reaches back 4 generations to 2000. 2 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.

Decided: Mar 15, 2007
Review: 143 days
Class: Class II
Product code: DQX
Recalls: 1 (1 Class I)
Predicates: 4

Its longest line of descent runs back 4 generations to K002206 (2000). 7 ancestors in all, the oldest K903923 (1990). 1 later device descends from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
3 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
2 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
1 generation backK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
This deviceK063210 Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478…Medtronic Inc. Cardiac Rhythm Management · 2007
Descendant · cites it directly · 0 of its ownK143316 Attain Hybrid Guide WireMedtronic, Inc. · 2015

Class I recalls in this family

K983927 GT1 Floppy, GT1 HI-Per Flex, GT1 Light Supportdirect predicate · 1999

Most influential descendants

Showing 1 of 1 · See all

K143316Attain Hybrid Guide WireMedtronic, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidant Corp.	2000	—
−3	K013092	HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating	Guidant Corp.	2001	—
−2	K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat…	Guidant Corp.	2002	—
−1	K030019	Modification to HI-Torque Whisper Guidewire	Guidant Corp.	2003	—
0 (this device)	K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488	Medtronic Inc. Cardiac Rhythm Management	2007	—
+1	K143316	Attain Hybrid Guide Wire	Medtronic, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1999	1	1
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K063210, 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.

2 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? (4)

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
*	K030019	Modification to HI-Torque Whisper Guidewire Summary page 1 …• Guidant HI-TORQUE WHISPER - Guide Wires with Hydrocoat Hydrophilic Coating (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, 4583, and 4588) - K030019 cleared January 24, 2003. * Medtronic Stylet Kit Models 6254, 6282 and 6293 - K010906 cleared…	Guidant Corp.	2003	—
*	K010906	Medtronic Stylet Kit, Models 6282, 6293, and 6254 Summary page 1 …6738, 4482, 4483, 4581, 4586, 4583, and 4588) - K030019 cleared January 24, 2003. * Medtronic Stylet Kit Models 6254, 6282 and 6293 - K010906 cleared April 5, 2001 * Medtronic GT-l Guide Wires (Floppy, Hi-Per Flex and Light Support) - K983927…	Medtronic Vascular	2001	—
*	K983927	GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support Summary page 1 …* Medtronic Stylet Kit Models 6254, 6282 and 6293 - K010906 cleared April 5, 2001 * Medtronic GT-l Guide Wires (Floppy, Hi-Per Flex and Light Support) - K983927 cleared March 11, 1999 * Medtronic Silk Guide Wires - K903923 cleared November 21, 1990…	Arterial Vascular Engineering, Inc.	1999	Class I
*	K903923	Usci (R) Silk (TM) Guide Wire Summary page 1 …* Medtronic GT-l Guide Wires (Floppy, Hi-Per Flex and Light Support) - K983927 cleared March 11, 1999 * Medtronic Silk Guide Wires - K903923 cleared November 21, 1990 * MVedIt ronc'Confidential…	C.R. Bard, Inc.	1990	—

Also cleared against K030019: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K143316	Attain Hybrid Guide Wire	Medtronic, Inc.	2015	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 21, 2013	Class I	Z-0265-2014	Nonconforming Material/Component	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

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.

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

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
1 of the 7 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K143316 (Medtronic, Inc., 2015) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K030019.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063210 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063210: Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063210

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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