510(k) · Cleared
ClearedTransend EX Platinum Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQX Wire, Guide, Catheter
Cleared on Jul 1, 1997 after an 89-day review. The FDA summary names its predicate without a number. 39 later devices descend from it.
- Decided
- Jul 1, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 9 citing it directly.
- This deviceK971254 Transend EX Platinum GuidewireBoston Scientific Corp · 1997
- Descendant · cites it directly · 12 of its ownK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK110584 Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- Descendant · cites it directly · 10 of its ownK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · Recalled
- Descendant · 2 generations on · 9 of its ownK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
- Descendant · cites it directly · 9 of its ownK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008 · cites it directly12descendants
- K110584Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011 · cites it directly11descendants
- K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · cites it directly10descendants
- K133725Traxcess 14 GuidewireMicroVention, Inc. · 2014 · 2 generations on9descendants
- K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971254 | Transend EX Platinum Guidewire | Boston Scientific Corp | 1997 | — |
| +1 | K080863 | Traxcess 0.014 Hydrophilic Guidewire | MicroVention, Inc. | 2008 | — |
| +1 | K110584 | Asahi Chikai Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| +1 | K050964 | PV 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | 2005 | 6 |
| +2 | K133725 | Traxcess 14 Guidewire | MicroVention, Inc. | 2014 | — |
| +1 | K053268 | PVS 2000 SYNCHRO2 Guidewire | Boston Scientific - Precision Vascular | 2006 | 13 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | — | BSC Transend EX Steerable Guidewire Named without a submission number | |
| * | — | BSC Preceder Guidewire Named without a submission number | |
| * | — | Terumo Corporation’s Glidewire Gold Guidewire Named without a submission number |
What descends from it? (39)
See all 399 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080863 | Traxcess 0.014 Hydrophilic Guidewire | 2008 | 12 |
| K110584 | Asahi Chikai Neurovascular Guide Wire | 2011 | 11 |
| K050964 | PV 1900 Synchro 0.016 Guidewire | 2005 | 10 |
| K053268 | PVS 2000 SYNCHRO2 Guidewire | 2006 | 9 |
| K112979 | Asahi Chikai 10 Neurovascular Guide Wire | 2011 | 6 |
| K113716 | Asahi Chikai V Peripheral Vascular Guide Wire | 2012 | 1 |
| K113454 | 14 Wire Standard, 14 Wire LS | 2012 | 0 |
| K053265 | Micrus Guide Wire, Watusi 0.014 | 2006 | 0 |
| K051373 | Cronus Guidewire, Model 001-001470-1 | 2005 | 0 |
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, K080863 (MicroVention, Inc., 2008) has gone furthest, with 12 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 Transend EX Platinum Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.
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/K971254 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971254: Transend EX Platinum Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971254
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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