510(k) · Cleared
ClearedBoston Scientific V-18 Control Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQX Wire, Guide, Catheter
Cleared on Jan 12, 2004 as substantially equivalent to K934359 (Scimed Peripheral Interventions, 1993) after a 45-day review. Its family tree reaches back 1 generation to 1993. 3 of the 35 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.
- Decided
- Jan 12, 2004
- Review
- 45 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934359 (1993). 33 later devices descend from it, 2 citing it directly. 3 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK934359 Scimed Strike Steerable Guide WireScimed Peripheral Interventions · 1993
- This deviceK033742 Boston Scientific V-18 Control WireBoston Scientific Corp · 2004
- Descendant · cites it directly · 32 of its ownK061984 TreasureAsahi Intecc Co., Ltd. · 2006
- Descendant · 2 generations on · 27 of its ownK071721 Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007
- Descendant · 2 generations on · 21 of its ownK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
- Descendant · 2 generations on · 17 of its ownK083146 Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 &…Asahi Intecc Co., Ltd. · 2008
- Descendant · 3 generations on · 16 of its ownK150445 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd…Asahi Intecc Co., Ltd. · 2015
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K061984TreasureAsahi Intecc Co., Ltd. · 2006 · cites it directly32descendants
- K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007 · 2 generations on27descendants
- K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010 · 2 generations on21descendants
- K083146Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Asahi Intecc Co., Ltd. · 2008 · 2 generations on17descendants
- K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd. · 2015 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934359 | Scimed Strike Steerable Guide Wire | Scimed Peripheral Interventions | 1993 | — |
| 0 (this device) | K033742 | Boston Scientific V-18 Control Wire | Boston Scientific Corp | 2004 | — |
| +1 | K061984 | Treasure | Asahi Intecc Co., Ltd. | 2006 | — |
| +2 | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | 2007 | — |
| +2 | K103057 | Asahi Astato XS 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2010 | — |
| +2 | K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | Asahi Intecc Co., Ltd. | 2008 | — |
| +3 | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 1 |
| 2021 | 3 | 1 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 1 |
| 2026 | 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K934359 | Scimed Strike Steerable Guide WireSummary page 1…. Classification of Device Class 11, 21 CFR Part 870.1330 Predicate Devices Boston Scientific Strike TM (V- 18) Control Guide Wire (K934359; cleared October 7, 1993) Device Description The 110 cm V-18 Control Wire wire is for use in the percutaneous… | 1993 |
What descends from it? (33)
See all 332 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061984 (Asahi Intecc Co., Ltd., 2006) has gone furthest, with 32 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 110cm V-18 Control Wire is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018" guide wire in hemodialysis AV access procedures. The wire can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A torque device is included with each wire to facilitate directional manipulation of the guide wire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033742 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033742: Boston Scientific V-18 Control Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033742
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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