510(k) Report

510(k) · Cleared

Cleared

Cordis Steer-IT Deflecting Tip Guidewire

K040592510(k) TraditionalCleared Dec 17, 2004284-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 Dec 17, 2004 as substantially equivalent to K953760 (Cordis Corp., 1995) and 5 other predicates after a 284-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.

Decided
Dec 17, 2004
Review
284 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K970376 (1997). 7 ancestors in all, the oldest K881787 (1988). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor2007: 1 descendant cleared2017: 1 descendant clearedK970376 · Ptca Guidewire · Lake Region Mfg., Inc. · 1997K011968 · Streerable Ptca Guidewire · Lake Region Mfg., Inc. · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K011968 · Streerable Ptca Guidewire · Lake Region Mfg., Inc. · 2001 · recalledK970376 · Ptca Guidewire · Lake Region Mfg., Inc. · 19970
  1. Root · 2 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
  2. 1 generation backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
  3. This deviceK040592 Cordis Steer-IT Deflecting Tip GuidewireCordis Corp. · 2004
  4. Descendant · cites it directly · 1 of its ownK070212 CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM…Ovalum, Ltd. · 2007
  5. Descendant · 2 generations on · 0 of its ownK171897 Approach CTO Microwire GuideCook Incorporated · 2017 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd. · 2007 · cites it directly1descendant
  • K171897Approach CTO Microwire GuideCook Incorporated · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K970376Ptca GuidewireLake Region Mfg., Inc.1997—
−1K011968Streerable Ptca GuidewireLake Region Mfg., Inc.20012
0 (this device)K040592Cordis Steer-IT Deflecting Tip GuidewireCordis Corp.2004—
+1K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop…Ovalum, Ltd.2007—
+2K171897Approach CTO Microwire GuideCook Incorporated20173

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310
199510
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201710
FIG. 1 — Lineage of K040592, 1997–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K953760Cordis Wizdom Steerable Guidewire
Summary page 1
…er guidewires have been placed in Class II, 21 CFR 870.1330, Cathether Guide Wire. NAME OF PREDICATE DEVICES * Cordis Wizdomn Steerable Guidewire (K953760) Tm Deflection * USCI PilotWireTm Deflectable Guide Wire w…
Cordis Corp.1995—
*K934474Pilot Cardiovascular Systems 2 CM Pilot Wire
Summary page 2
…wing steerable guidewires: * Cordis Wizdom Steerable Guidewire (K953760) • USCI PilotWireTM Deflectable Guide Wire with CommanderTM Deflection Handle (K934474) · Lake Region Manufacturing, Inc. Mandrel Guidewire (KO I1084) · Lake Region Manufacturing, Inc. Steerable PTCA Guide…
Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard1993—
*K011084Mandrel Guidewire Assembly
Summary page 1
…Tm Deflection * USCI PilotWireTm Deflectable Guide Wire with Commander Handle (K(934474) * Lake Region Manufacturing, Inc. Mandrel Guidewire (KO011084) * Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K1(011968) * ACS High Torque Standard (1(881787)…
Lake Region Mfg., Inc.2001—
*K011968Streerable Ptca Guidewire
Summary page 1
…er Handle (K(934474) * Lake Region Manufacturing, Inc. Mandrel Guidewire (KO011084) * Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K1(011968) * ACS High Torque Standard (1(881787) * Cordis ATW Marker Wire (K994358) PERFORMANCE STANDARDS Per…
Lake Region Mfg., Inc.20012
*K881787Acs HI-Torque Standard & Intermedi. Guide Wire
Summary page 2
…ake Region Manufacturing, Inc. Mandrel Guidewire (KO I1084) · Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K1011968) * ACS High Torque Standard (K881787) * Cordis ATW Marker Wire (K994358) They are all .014" diameter guidewires used to support the advancement of de…
Advanced Cardiovascular Systems, Inc.1988—
*K994358Atw Marker Wire Steerable Guidewire
Summary page 1
…re (KO011084) * Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K1(011968) * ACS High Torque Standard (1(881787) * Cordis ATW Marker Wire (K994358) PERFORMANCE STANDARDS Performance standards have not been established by the FDA under Section 514 of the…
Cordis Corp.2000—

Also cleared against K953760: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071

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?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K070212 (Ovalum, Ltd., 2007) has gone furthest, with 1 descendant of its own.
  • 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

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
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

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The Cordis STEER-IT Deflecting Tip 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 as stated in the FDA summary.

Also cleared against K953760

3 other devices cite the same predicate.

  • K990823PVS 1400 GuidewirePrecision Vascular Systems, Inc. · 1999
  • K963214Cordis ST Steerable GuidewireCordis Corp. · 1996
  • K962932Cordis Stabilizer Plus XSCordis Corp. · 1996

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K040592 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040592: Cordis Steer-IT Deflecting Tip Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040592

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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