510(k) · Cleared
ClearedLuge Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Jan 12, 1998 after an 88-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jan 12, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK973945 Luge Guide WireScimed Life Systems, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
- Descendant · 2 generations on · 3 of its ownK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled
- Descendant · 3 generations on · 1 of its ownK081021 Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008
- Descendant · 4 generations on · 0 of its ownK193194 CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK052783 Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K032183IQ Hydrophilic Guide WireBoston Scientific Corp · 2003 · cites it directly4descendants
- K040140IQ Guide WireBoston Scientific Corp · 2004 · 2 generations on3descendants
- K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008 · 3 generations on1descendant
- K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019 · 4 generations on0descendants
- K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973945 | Luge Guide Wire | Scimed Life Systems, Inc. | 1998 | — |
| +1 | K032183 | IQ Hydrophilic Guide Wire | Boston Scientific Corp | 2003 | — |
| +2 | K040140 | IQ Guide Wire | Boston Scientific Corp | 2004 | 1 |
| +3 | K081021 | Kinetix Guidewire, Plus Guidewire | Boston Scientific Corp | 2008 | — |
| +4 | K193194 | CrossTorq 14 Guidewire | Scientia Cardio Access, LLC | 2019 | — |
| +3 | K052783 | Modification to: IQ Guide Wire, Models 38950-XX. 38951-XX | Boston Scientific Corp | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ChoICE Family of Guide Wires Named without a submission number | |
| * | — | Sceptor Family of Guide Wires Named without a submission number | |
| * | — | ChoICE PT Family of Guide Wires Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K032183 (Boston Scientific Corp, 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 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 SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
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/K973945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973945: Luge Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973945
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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