510(k) Report

510(k) · Cleared

Cleared

Atw Marker Wire Steerable Guidewire

K994358510(k) SpecialCleared Jan 13, 200017-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 Jan 13, 2000 after a 17-day review. The FDA summary names its predicate without a number. 5 of the 47 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it.

Decided
Jan 13, 2000
Review
17 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

46 later devices descend from it, 3 citing it directly. 5 of the 47 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2007: 2 descendants cleared2008: 1 descendant cleared2012: 7 descendants cleared2010: 2 descendants cleared2009: 3 descendants cleared2013: 1 descendant cleared2017: 1 descendant cleared2011: 1 descendant cleared2023: 4 descendants cleared, 1 with a Class I recall12020: 2 descendants cleared2026: 4 descendants cleared2014: 3 descendants cleared2025: 5 descendants cleared, 1 with a Class I recall12015: 1 descendant cleared2019: 2 descendants cleared, 1 with a Class I recall12016: 1 descendant cleared2018: 1 descendant cleared2024: 3 descendants cleared, 2 with a Class I recall22021: 1 descendant cleared200020052010201520202025
  1. This deviceK994358 Atw Marker Wire Steerable GuidewireCordis Corp. · 2000
  2. Descendant · cites it directly · 35 of its ownK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
  3. Descendant · 2 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
  4. Descendant · 3 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
  5. Descendant · 3 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
  6. Descendant · 3 generations on · 11 of its ownK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2004: 12007: 22008: 12009: 32010: 22011: 12012: 72013: 12014: 32015: 12016: 12017: 12018: 12019: 22020: 22021: 12023: 42024: 32025: 52026: 4
2004high 7 (2012) · low 0 (2005)2026

Class I recalls in this family

  • K190106 Intra-Operative Positioning System; Simple Curve…5 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
  • K241243 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
  • K230309 Intra-Operative Positioning System (IOPS®)…6 generations on · 2023

Most influential descendants

Showing 5 of 46 · See all
  • K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007 · cites it directly35descendants
  • K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 2 generations on30descendants
  • K110256The IC-Pro SystemPaieon, Inc. · 2011 · 3 generations on15descendants
  • K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 3 generations on13descendants
  • K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994358Atw Marker Wire Steerable GuidewireCordis Corp.2000—
+1K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC2007—
+2K083745The IC-Pro System, Model Version 3.2Paieon, Inc.2009—
+3K110256The IC-Pro SystemPaieon, Inc.2011—
+3K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV2010—
+3K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200720
200810
200930
201020
201110
201270
201310
201430
201510
201610
201710
201810
201921
202020
202110
202341
202432
202551
202640
FIG. 1 — Lineage of K994358, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

5 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. #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? (3)

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
*—ST Steerable Guidewire
Named without a submission number
—
*—Wizdom Marker Wire
Named without a submission number
—
*—Stabilizer Marker Wire Steerable Guidewires
Named without a submission number
—

What descends from it? (46)

See all 46

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

NumberDeviceApplicantDecidedDescendants
K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC200735
K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086
K040592Cordis Steer-IT Deflecting Tip GuidewireCordis Corp.20042

Has anything in its family been recalled? (5 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.

  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K062192 (Ostial Solutions, LLC, 2007) has gone furthest, with 35 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)—

What is it indicated for?

The Cordis guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool.

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

  • 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/K994358 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994358: Atw Marker Wire 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/K994358

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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