510(k) · Cleared
ClearedScimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca 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 May 15, 1996 after a 63-day review. The FDA summary names its predicate without a number. 1 of the 31 devices in its family, counting itself, has a Class I recall. 30 later devices descend from it.
- Decided
- May 15, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 6 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- This deviceK961015 Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca…Scimed Life Systems, Inc. · 1996
- Descendant · cites it directly · 16 of its ownK962572 Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 11 of its ownK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
- Descendant · cites it directly · 10 of its ownK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- Descendant · 2 generations on · 8 of its ownK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 6 of its ownK143587 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT…Boston Scientific Corporation · 2015 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080364 Findrwirz Guide Wire System4 generations on · 2008
Most influential descendants
Showing 5 of 30 · See all- K962572Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1996 · cites it directly16descendants
- K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · 2 generations on11descendants
- K970244Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997 · cites it directly10descendants
- K021363Endovascular Guide WireStereotaxis, Inc. · 2002 · 2 generations on8descendants
- K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation · 2015 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961015 | Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire | Scimed Life Systems, Inc. | 1996 | — |
| +1 | K962572 | Scimed Choice PT Vision Ptca Guide Wire | Scimed Life Systems, Inc. | 1996 | 3 |
| +2 | K030617 | PT2 Guide Wire and Addwire Extension Wire | Boston Scientific Scimed, Inc. | 2003 | 4 |
| +1 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| +2 | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | 6 |
| +3 | K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire… | Boston Scientific Corporation | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 1 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | — | SCIMED ChoICE™ PTCA Guide Wire Named without a submission number | |
| * | — | SCIMED ChoICE™ Plus PTCA Guide Wire Named without a submission number | |
| * | — | SCIMED ChoICE™ Exchange PTCA Guide Wire Named without a submission number |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962572 | Scimed Choice PT Vision Ptca Guide Wire | 1996 | 16 |
| K970244 | Scimed Choice Family of Ptca Guide Wires | 1997 | 10 |
| K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice… | 1997 | 4 |
| K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire | 1997 | 2 |
| K974241 | Scimed Informer Pressure Wire System | 1998 | 0 |
| K980360 | Scimed Quest Floppy and Moderate Support Guide Wires | 1998 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K962572 (Scimed Life Systems, Inc., 1996) has gone furthest, with 16 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 ChoICE™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE™ Guide Wire family 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/K961015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961015: Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca 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/K961015
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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