510(k) · Cleared
Recalled · 2008Platinum Plus 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 Jun 17, 1994 after a 184-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 46 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 17, 1994
- Review
- 184 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 6
- Predicates
- 0
45 later devices descend from it, 4 citing it directly. 3 of the 46 devices in this family, counting this one, have a Class I recall.
- This deviceK935997 Platinum Plus GuidewireBoston Scientific Corp · 1994
- Descendant · cites it directly · 36 of its ownK963702 Acs HI-Torque Iron Man Guide WireAdvanced Cardiovascular Systems, Inc. · 1997
- Descendant · 2 generations on · 34 of its ownK982876 HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281…Guidant Corp. · 1998
- Descendant · 3 generations on · 32 of its ownK061984 TreasureAsahi Intecc Co., Ltd. · 2006
- Descendant · 3 generations on · 27 of its ownK071721 Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007
- Descendant · 4 generations on · 21 of its ownK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 45 · See all- K963702Acs HI-Torque Iron Man Guide WireAdvanced Cardiovascular Systems, Inc. · 1997 · cites it directly36descendants
- K982876HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282Guidant Corp. · 1998 · 2 generations on34descendants
- K061984TreasureAsahi Intecc Co., Ltd. · 2006 · 3 generations on32descendants
- K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007 · 3 generations on27descendants
- K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935997 | Platinum Plus Guidewire | Boston Scientific Corp | 1994 | — |
| +1 | K963702 | Acs HI-Torque Iron Man Guide Wire | Advanced Cardiovascular Systems, Inc. | 1997 | — |
| +2 | K982876 | HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282 | Guidant Corp. | 1998 | — |
| +3 | K061984 | Treasure | Asahi Intecc Co., Ltd. | 2006 | — |
| +3 | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | 2007 | — |
| +4 | K103057 | Asahi Astato XS 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 1 |
| 2020 | 1 | 0 |
| 2021 | 3 | 1 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 1 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 454 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2008 | Not classified | Z-0030-2009 | Labeling mix-ups | Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and… |
| Aug 25, 2008 | Not classified | Z-0031-2009 | Labeling mix-ups | Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire… |
| Jun 19, 2008 | Not classified | Z-2365-2008 | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary… |
| Jun 19, 2008 | Not classified | Z-2364-2008 | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary… |
| Jun 19, 2008 | Not classified | Z-2363-2008 | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary… |
| Jun 19, 2008 | Not classified | Z-2362-2008 | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary… |
The 5 latest of 6 recalls; the web page lists all.
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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K963702 (Advanced Cardiovascular Systems, Inc., 1997) has gone furthest, with 36 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) | — |
https://510kreport.com/device/K935997 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935997: Platinum Plus Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935997
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026