510(k) · Cleared
Recalled · 2010PV 1900 Synchro 0.016 Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific - Precision Vascular · DQX Wire, Guide, Catheter
Cleared on Jun 13, 2005 as substantially equivalent to K032146 (Precision Vascular Systems, Inc., 2003) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 2000. 10 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 13, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 2 generations to K002212 (2000). 4 ancestors in all, the oldest K913074 (1991). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 1 generation backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- This deviceK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005
- Descendant · cites it directly · 9 of its ownK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK202522 Synchro SELECT GuidewireStryker Neurovascular · 2020 · Recalled
- Descendant · 3 generations on · 4 of its ownK243756 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · 4 generations on · 3 of its ownK253168 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · 5 generations on · 1 of its ownK260130 Willow 18 GuidewireArbor Endovascular, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · cites it directly9descendants
- K202522Synchro SELECT GuidewireStryker Neurovascular · 2020 · 2 generations on6descendants
- K2437560.014” Willow GuidewireArbor Endovascular, LLC · 2025 · 3 generations on4descendants
- K2531680.014” Willow GuidewireArbor Endovascular, LLC · 2025 · 4 generations on3descendants
- K260130Willow 18 GuidewireArbor Endovascular, LLC · 2026 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −1 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| 0 (this device) | K050964 | PV 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | 2005 | — |
| +1 | K053268 | PVS 2000 SYNCHRO2 Guidewire | Boston Scientific - Precision Vascular | 2006 | 13 |
| +2 | K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020 | 1 |
| +3 | K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +4 | K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +5 | K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresSummary page 1…Device Manufacturer 510(k) Number/Date Pro Code Predicate SynchroTM .014" Precision Vascular K032146, 12 Aug 2003 DQX Devices SynchroTM .010" Precision Vascular K032146, 12 Aug 2003… | 2003 |
| * | K971254 | Transend EX Platinum GuidewireSummary page 1…Devices SynchroTM .010" Precision Vascular K032146, 12 Aug 2003 DQX Transend Target Therapeutics K971254, 01 Jul 1997* DOX Agility-16 Cordis K01lO5il, 01 Mar 2001t… | 1997 |
| Kept off the family tree | K011051 | Agility-16 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K913074 | 0.016 Guide Wire for Neurological EndoscopeSummary page 1…Agility-16 Cordis K01lO5il, 01 Mar 2001t DQX 0.016" Guidewire Terumo K913074, 05 Nov 1991* DQX *This information is assumed based upon our best knowledge. Classificati… | 1991 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053268 | PVS 2000 SYNCHRO2 Guidewire | 2006 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2010 | Not classified | Z-0878-2011 | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. |
| Jun 7, 2010 | Not classified | Z-0879-2011 | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. |
| Jun 7, 2010 | Not classified | Z-0876-2011 | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. |
| Jun 7, 2010 | Not classified | Z-0877-2011 | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. |
| Jun 7, 2010 | Not classified | Z-0881-2011 | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. |
| Jun 7, 2010 | Not classified | Z-0880-2011 | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K053268 (Boston Scientific - Precision Vascular, 2006) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K032146.
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 PV 1900 Synchro® 0.016" Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050964: PV 1900 Synchro 0.016 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050964
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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