510(k) · Cleared

Cleared

Cordis ST Steerable Guidewire

K963214510(k) TraditionalCleared Nov 13, 199689-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

Cordis Corp. · DQX Wire, Guide, Catheter

Cleared on Nov 13, 1996 as substantially equivalent to K953760 (Cordis Corp., 1995) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1988.

Decided: Nov 13, 1996
Review: 89 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K881897 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881897 Acs HI-Torque Floppy/Floppy II/Inter./Standard GWAdvanced Cardiovascular Systems, Inc. · 1988
This deviceK963214 Cordis ST Steerable GuidewireCordis Corp. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881897	Acs HI-Torque Floppy/Floppy II/Inter./Standard GW	Advanced Cardiovascular Systems, Inc.	1988	—
0 (this device)	K963214	Cordis ST Steerable Guidewire	Cordis Corp.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K963214, 1988–1996Source: 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.

Planning a device in DQX? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K953760	Cordis Wizdom Steerable Guidewire Summary page 1 …neral Provisions Common or Usual Name: Catheter Guide Wire Proprietary Name: Cordis ST Steerable Guidewire Name of Predicate Devices Cordis WIZDOM Steerable Guidewire (K953760) ACS HI-TORQUE FLOPPY/FLOPPY Il/Intermediate/Standard Guide Wire (K881897) Classification Catheter Guide Wire, Class I - 21 CFR…	Cordis Corp.	1995	—
*	K881897	Acs HI-Torque Floppy/Floppy II/Inter./Standard GW Summary page 1 …: Cordis ST Steerable Guidewire Name of Predicate Devices Cordis WIZDOM Steerable Guidewire (K953760) ACS HI-TORQUE FLOPPY/FLOPPY Il/Intermediate/Standard Guide Wire (K881897) Classification Catheter Guide Wire, Class I - 21 CFR 870.1330 74DQX - Cardiovascular Devices Performance Standards Performanc…	Advanced Cardiovascular Systems, Inc.	1988	—

Also cleared against K953760: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K953760.

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 Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral 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/K963214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963214: Cordis ST Steerable Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963214

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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