510(k) · Cleared

Cleared

Vascular Guide Wire

K913353510(k) TraditionalCleared Oct 23, 199189-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

Advanced Cardiovascular Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Oct 23, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 56 devices in its family, counting itself, have a Class I recall. 55 later devices descend from it.

Decided: Oct 23, 1991
Review: 89 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

55 later devices descend from it, 2 citing it directly. 2 of the 56 devices in this family, counting this one, have a Class I recall.

This deviceK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
Descendant · cites it directly · 53 of its ownK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
Descendant · 2 generations on · 43 of its ownK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
Descendant · 3 generations on · 26 of its ownK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
Descendant · 4 generations on · 21 of its ownK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
Descendant · 2 generations on · 13 of its ownK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

1997high 6 (2008) · low 0 (2000)2026

Class I recalls in this family

K080364 Findrwirz Guide Wire System4 generations on · 2008
K121398 Charlie Guidewire (Regular), Charlie Guidewire…5 generations on · 2012

Most influential descendants

Showing 5 of 55 · See all

K971815Asc Balance Middleweight Guide WireGuidant Corp. · 1997 · cites it directly53descendants
K973494HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Guidant Corp. · 1997 · 2 generations on43descendants
K013833HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2002 · 3 generations on26descendants
K072460HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008 · 4 generations on21descendants
K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913353	Vascular Guide Wire	Advanced Cardiovascular Systems, Inc.	1991	—
+1	K971815	Asc Balance Middleweight Guide Wire	Guidant Corp.	1997	—
+2	K973494	HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque…	Guidant Corp.	1997	—
+3	K013833	HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic…	Guidant Corp.	2002	—
+4	K072460	HI-Torque Balance Middleweight Universal II Guide Wire	Abbott Vascular, Inc.	2008	—
+2	K103101	HI-Torque Balance Middleweight Elite	Abbott Vascular-Cardiac Therapies	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	1	0
1999	2	0
2002	2	0
2003	3	0
2004	1	0
2005	5	0
2006	2	0
2008	6	1
2009	2	0
2010	4	0
2011	2	0
2012	2	1
2013	1	0
2014	2	0
2015	4	0
2016	1	0
2017	3	0
2018	3	0
2019	4	0
2020	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K913353, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K971815	Asc Balance Middleweight Guide Wire	Guidant Corp.	1997	53
K984394	Acs HI-Torque Wiggle Guide Wire with Microglide Coating	Guidant Corp.	1999	0

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.

K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls

What does this lineage say?

Of its descendants, K971815 (Guidant Corp., 1997) has gone furthest, with 53 descendants of its own.

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)	—

https://510kreport.com/device/K913353 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913353: Vascular 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/K913353

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026