510(k) Report

510(k) · Cleared

Cleared

Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom with Radiopaque Markers)

K962765510(k) TraditionalCleared Feb 21, 1997220-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 Feb 21, 1997 as substantially equivalent to K952067 (Cordis Corp., 1995) and 2 other predicates after a 220-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.

Decided
Feb 21, 1997
Review
220 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K941269 (1994). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor2000: 1 descendant cleared2005: 1 descendant clearedK941269 · Gore Smoother II and Gore BPTB · W. L. Gore & Associates, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K941269 · Gore Smoother II and Gore BPTB · W. L. Gore & Associates, Inc. · 19940
  1. Root · 1 generation backK941269 Gore Smoother II and Gore BPTBW. L. Gore & Associates, Inc. · 1994
  2. This deviceK962765 Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque…Cordis Corp. · 1997
  3. Descendant · cites it directly · 1 of its ownK993248 Amplatzer Sizing BalloonAga Medical Corp. · 2000
  4. Descendant · 2 generations on · 0 of its ownK053440 Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K993248Amplatzer Sizing BalloonAga Medical Corp. · 2000 · cites it directly1descendant
  • K053440Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941269Gore Smoother II and Gore BPTBW. L. Gore & Associates, Inc.1994—
0 (this device)K962765Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers)…Cordis Corp.1997—
+1K993248Amplatzer Sizing BalloonAga Medical Corp.2000—
+2K053440Amplatzer Sizing Balloon IIAga Medical Corp.20052

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200510
FIG. 1 — Lineage of K962765, 1994–2005Source: 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), 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? (4)

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
*K952067Cordis Steerable Guidewire
Summary page 1
…e: Cordis STABILIZER Marker Wire Steerable Guidewire Cordis WIZDOM Marker Wire Steerable Guidewire Name of Predicate Devices Cordis STABILIZER with Radiopaque Markers (K952067 and K953750) Cordis WIZDOM with Radiopaque Markers (K953750) Gore SMOOTHER II (K941269) Rulers and Calipers Classification Cat…
Cordis Corp.1995—
*K953750Catheter, Electrode Recording, or Probe, Electrode Recording
Summary page 1
…ABILIZER Marker Wire Steerable Guidewire Cordis WIZDOM Marker Wire Steerable Guidewire Name of Predicate Devices Cordis STABILIZER with Radiopaque Markers (K952067 and K953750) Cordis WIZDOM with Radiopaque Markers (K953750) Gore SMOOTHER II (K941269) Rulers and Calipers Classification Catheter Guide…
Boston Scientific Corp1996—
*K941269Gore Smoother II and Gore BPTB
Summary page 1
…Guidewire Name of Predicate Devices Cordis STABILIZER with Radiopaque Markers (K952067 and K953750) Cordis WIZDOM with Radiopaque Markers (K953750) Gore SMOOTHER II (K941269) Rulers and Calipers Classification Catheter Guide Wire, Class I - 21 CFR 870.1330 74DQX - Cardiovascular Performance Standar…
W. L. Gore & Associates, Inc.1994—
*—Rulers and Calipers
Named without a submission number
—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K993248Amplatzer Sizing BalloonAga Medical Corp.20001

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 3 ancestors has a recall.
  • Of its descendants, K993248 (Aga Medical Corp., 2000) has gone furthest, with 1 descendant 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)—

What is it indicated for?

The Cordis STABILIZER Marker Wire Steerable Guidewire and Cordis WIZDOM Marker Wire Steerable Guidewire 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.

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

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  • 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/K962765 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962765: Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom with Radiopaque Markers).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962765

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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