510(k) Report

510(k) · Cleared

Cleared

Cordis Steerable Guidewire

K952067510(k) TraditionalCleared Jul 20, 199579-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 Jul 20, 1995 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jul 20, 1995
Review
79 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2000: 1 descendant cleared2005: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952067 Cordis Steerable GuidewireCordis Corp. · 1995
  2. Descendant · cites it directly · 2 of its ownK962765 Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque…Cordis Corp. · 1997
  3. Descendant · 2 generations on · 1 of its ownK993248 Amplatzer Sizing BalloonAga Medical Corp. · 2000
  4. Descendant · 3 generations on · 0 of its ownK053440 Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K962765Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom…Cordis Corp. · 1997 · cites it directly2descendants
  • K993248Amplatzer Sizing BalloonAga Medical Corp. · 2000 · 2 generations on1descendant
  • K053440Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952067Cordis Steerable GuidewireCordis Corp.1995—
+1K962765Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers)…Cordis Corp.1997—
+2K993248Amplatzer Sizing BalloonAga Medical Corp.2000—
+3K053440Amplatzer Sizing Balloon IIAga Medical Corp.20052

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200510
FIG. 1 — Lineage of K952067, 1995–2005Source: 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), 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?

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

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K962765Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom…Cordis Corp.19972

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?

  • Of its descendants, K962765 (Cordis Corp., 1997) has gone furthest, with 2 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

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)—

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/K952067 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952067: Cordis 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/K952067

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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