510(k) · Cleared
Recalled · 2006PT2 Guide Wire and Addwire Extension Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · DQX Wire, Guide, Catheter
Cleared on May 21, 2003 as substantially equivalent to K962572 (Scimed Life Systems, Inc., 1996) and 6 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1991. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- May 21, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 4
- Predicates
- 7
Its longest line of descent runs back 3 generations to K913353 (1991). 19 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 2 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 1 generation backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- This deviceK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK143587 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT…Boston Scientific Corporation · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
- Descendant · 2 generations on · 3 of its ownK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK152231 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation · 2016
- Descendant · 3 generations on · 1 of its ownK081021 Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation · 2015 · cites it directly6descendants
- K032183IQ Hydrophilic Guide WireBoston Scientific Corp · 2003 · cites it directly4descendants
- K040140IQ Guide WireBoston Scientific Corp · 2004 · 2 generations on3descendants
- K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation · 2016 · 2 generations on2descendants
- K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −2 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −1 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| 0 (this device) | K030617 | PT2 Guide Wire and Addwire Extension Wire | Boston Scientific Scimed, Inc. | 2003 | — |
| +1 | K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire… | Boston Scientific Corporation | 2015 | 1 |
| +1 | K032183 | IQ Hydrophilic Guide Wire | Boston Scientific Corp | 2003 | — |
| +2 | K040140 | IQ Guide Wire | Boston Scientific Corp | 2004 | 1 |
| +2 | K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire | Boston Scientific Corporation | 2016 | — |
| +3 | K081021 | Kinetix Guidewire, Plus Guidewire | Boston Scientific Corp | 2008 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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.
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? (7)
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 |
|---|---|---|---|
| * | K962572 | Scimed Choice PT Vision Ptca Guide WireSummary page 1…Predicate Devices BSC Scimed (Clearance Date) PT GrriuhkTM K962572 December 17, 1996 Advanced Cardiovascular Systems, lnc. (ACS) Balance… | 1996 |
| * | K021228 | HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the… | 2002 |
| * | K983033 | Acs HT Balance Middleweight Guide WireSummary page 1…Balance KO2 1228 May 5,2002 Middle W e i g h P (BMW) K983033 November 0, 1998 K973494 December 2, 1997… | 1998 |
| * | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Summary page 1…Middle W e i g h P (BMW) K983033 November 0, 1998 K973494 December 2, 1997 K971815 July 9, 1997… | 1997 |
| * | K971815 | Asc Balance Middleweight Guide WireSummary page 1…November 0, 1998 K973494 December 2, 1997 K971815 July 9, 1997 Lake Region Manufacturing, Inc. (LRM) Extension Wire’… | 1997 |
| * | K970376 | Ptca GuidewireSummary page 1…K971815 July 9, 1997 Lake Region Manufacturing, Inc. (LRM) Extension Wire’ K970376 June 6, 1997 Steerable PTCA G W’ KO1 1968 July 25, 200 1… | 1997 |
| * | K011968 | Streerable Ptca Guidewire | 2001 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix… | 2015 | 6 |
| K032183 | IQ Hydrophilic Guide Wire | 2003 | 4 |
| K180726 | Savion DLVR Guidewire, Savion FLX Guidewire | 2018 | 0 |
| K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2006 | Not classified | Z-1540-06 | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. |
| Aug 31, 2006 | Not classified | Z-1538-06 | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. |
| Aug 31, 2006 | Not classified | Z-1541-06 | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. |
| Aug 31, 2006 | Not classified | Z-1539-06 | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K143587 (Boston Scientific Corporation, 2015) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K962572.
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 PT2TMGuide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TMGuide Wires are not intended for use in the cerebral vasculature.
The AddWireTMExtension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030617: PT2 Guide Wire and Addwire Extension Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030617
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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