510(k) · Cleared
Recalled · Class II · 2016ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DQX Wire, Guide, Catheter
Cleared on Jan 15, 2015 as substantially equivalent to K030617 (Boston Scientific Scimed, Inc., 2003) after a 28-day review. Its family tree reaches back 4 generations to 1991. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 15, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913353 (1991). 20 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 3 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 2 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 1 generation backK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
- This deviceK143587 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT…Boston Scientific Corporation · 2015
- Descendant · cites it directly · 2 of its ownK152231 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK193194 CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019
- Descendant · cites it directly · 0 of its ownK180726 Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK180795 JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific · 2018
- Descendant · cites it directly · 0 of its ownK170532 True Form Reshapable Guide WireMerit Medical Systems, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation · 2016 · cites it directly2descendants
- K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019 · 2 generations on0descendants
- K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc. · 2018 · cites it directly0descendants
- K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific · 2018 · 2 generations on0descendants
- K170532True Form Reshapable Guide WireMerit Medical Systems, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −3 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −2 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −1 | K030617 | PT2 Guide Wire and Addwire Extension Wire | Boston Scientific Scimed, Inc. | 2003 | 4 |
| 0 (this device) | K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire… | Boston Scientific Corporation | 2015 | — |
| +1 | K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire | Boston Scientific Corporation | 2016 | — |
| +2 | K193194 | CrossTorq 14 Guidewire | Scientia Cardio Access, LLC | 2019 | — |
| +1 | K180726 | Savion DLVR Guidewire, Savion FLX Guidewire | Boston Scientific, Inc. | 2018 | — |
| +2 | K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire | Boston Scientific | 2018 | — |
| +1 | K170532 | True Form Reshapable Guide Wire | Merit Medical Systems, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K030617 | PT2 Guide Wire and Addwire Extension WireSummary page 4…Catheter Guide Wire Classification: II Product Code: DQX per CFR Part 870.1330 Primary Predicate Device: PT² Guide Wire and AddWire™ Extension Wire (K030617, 21 May 2003) Reference Predicate Device: Luge Guide Wires (K973945, 12 January 1998) Mailman (ChoICE Family Super Support/Super… | 2003 |
| † | K973945 | Luge Guide Wire | 1998 |
| † | K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice… | 1997 |
| † | K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire | 1997 |
| † | K970244 | Scimed Choice Family of Ptca Guide Wires | 1997 |
| † | K962572 | Scimed Choice PT Vision Ptca Guide Wire | 1996 |
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2016 | Class II | Z-1370-2016 | Process control | Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K152231 (Boston Scientific Corporation, 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K030617.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
Boston Scientific ChoICE™ PT, PT Graphix™, ChoICE, Luge, and Mailman Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
Boston Scientific ChoICE™ PT Magnet, PT Graphix™ Magnet, ChoICE Magnet, Luge Magnet, and Mailman Magnet Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143587
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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