510(k) · Cleared

Cleared

Attain Hybrid Guide Wire

K143316510(k) TraditionalCleared Mar 11, 2015112-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 Mar 11, 2015 as substantially equivalent to K063210 (Medtronic Inc. Cardiac Rhythm Management, 2007) after a 112-day review. Its family tree reaches back 5 generations to 2000. 2 of the 9 devices in its family, counting itself, have a Class I recall.

Decided: Mar 11, 2015
Review: 112 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K002206 (2000). 8 ancestors in all, the oldest K903923 (1990). No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
4 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
3 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
2 generations backK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
1 generation backK063210 Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478…Medtronic Inc. Cardiac Rhythm Management · 2007 · Recalled (Class I)
This deviceK143316 Attain Hybrid Guide WireMedtronic, Inc. · 2015

Class I recalls in this family

K063210 Attain Hybrid Guide Wires, Model GWR419378…direct predicate · 2007
K983927 GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support2 generations back · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidant Corp.	2000	—
−4	K013092	HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating	Guidant Corp.	2001	—
−3	K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat…	Guidant Corp.	2002	—
−2	K030019	Modification to HI-Torque Whisper Guidewire	Guidant Corp.	2003	—
−1	K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488	Medtronic Inc. Cardiac Rhythm Management	2007	Class I
0 (this device)	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

FIG. 1 — Lineage of K143316, 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 Summary page 4 …t Code: DQX Classification: Class II Classification Panel: Cardiovascular Special Controls: Not applicable Predicate Devices: Attain Hybrid Guide Wires K063210 510(k) Summary Page 1 Device Description A guide wire is a…	Medtronic Inc. Cardiac Rhythm Management	2007	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K983927GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 1999 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
2 of the 8 ancestors have a recall of any class; 2 have a Class I recall.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K143316 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143316: Attain Hybrid Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143316

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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