510(k) · Cleared
ClearedClyde Coronary Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schneider (Europe) GmbH · DQX Wire, Guide, Catheter
Cleared on Jun 10, 1997 after a 119-day review. The FDA summary names its predicate without a number. 73 later devices descend from it.
- Decided
- Jun 10, 1997
- Review
- 119 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
73 later devices descend from it, 1 citing it directly.
- This deviceK970528 Clyde Coronary GuidewireSchneider (Europe) GmbH · 1997
- Descendant · cites it directly · 72 of its ownK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
- Descendant · 2 generations on · 69 of its ownK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
- Descendant · 3 generations on · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- Descendant · 3 generations on · 32 of its ownK031005 Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
- Descendant · 4 generations on · 31 of its ownK033535 Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002 · cites it directly72descendants
- K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 2003 · 2 generations on69descendants
- K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · 3 generations on36descendants
- K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003 · 3 generations on32descendants
- K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970528 | Clyde Coronary Guidewire | Schneider (Europe) GmbH | 1997 | — |
| +1 | K013284 | Lumend Frontrunner Cto Coronary Catheter | Lumend, Inc. | 2002 | — |
| +2 | K023114 | Lumend Frontrunner Cto Catheter | Lumend, Inc. | 2003 | — |
| +3 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| +3 | K031005 | Lumend Frontrunner GW Cto Catheter | Lumend, Inc. | 2003 | — |
| +4 | K033535 | Lumend Frontrunner Cto Catheter and Accessories | Lumend, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | — | C-Thru Coronary Guidewire Named without a submission number |
What descends from it? (73)
See all 731 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013284 | Lumend Frontrunner Cto Coronary Catheter | 2002 | 72 |
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, K013284 (Lumend, Inc., 2002) has gone furthest, with 72 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 Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.
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/K970528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970528: Clyde Coronary Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970528
Report an extraction error
Are you the manufacturer?
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