510(k) · Cleared
ClearedScimed Choice (TM) Ptca Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 22, 1994 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 31 devices in its family, counting itself, has a Class I recall. 30 later devices descend from it.
- Decided
- Nov 22, 1994
- Review
- 140 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 5 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- This deviceK943192 Scimed Choice (TM) Ptca Guide WireScimed Life Systems, Inc. · 1994
- 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) | K943192 | Scimed Choice (TM) Ptca Guide Wire | Scimed Life Systems, Inc. | 1994 | — |
| +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), 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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? (30)
See all 305 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 |
| 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 DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
https://510kreport.com/device/K943192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943192: Scimed Choice (TM) Ptca Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943192
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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