510(k) · Cleared
Recalled · 2002Scimed Choice PT Exchange Extra Support Ptca and Long Taper 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 Apr 29, 1996 after a 73-day review. The FDA summary names its predicate without a number. 1 of the 28 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it. It has been recalled once.
- Decided
- Apr 29, 1996
- Review
- 73 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 0
27 later devices descend from it, 3 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- This deviceK960657 Scimed Choice PT Exchange Extra Support Ptca and Long Taper 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 27 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 27 · 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) | K960657 | Scimed Choice PT Exchange Extra Support Ptca and Long Taper 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 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 1 |
| 2011 | 1 | 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 PT PTCA Guide Wire Named without a submission number | |
| * | — | SCIMED ChoICE PT Plus PTCA Guide Wire Named without a submission number | |
| * | — | SCIMED ChoICE PT Exchange PTCA Guide Wire Named without a submission number |
What descends from it? (27)
See all 273 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2002 | Not classified | Z-0590-03 | Other | Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm |
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 CholCE PT, ChoICE PT Plus and CholICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are intended to facilitate the placement asé exshamge of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are 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/K960657 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960657: Scimed Choice PT Exchange Extra Support Ptca and Long Taper 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/K960657
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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