510(k) · Cleared
Recalled · Class II · 2024PVS 2000 SYNCHRO2 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 Mar 13, 2006 as substantially equivalent to K032146 (Precision Vascular Systems, Inc., 2003) and 2 other predicates after a 110-day review. Its family tree reaches back 3 generations to 2000. 9 later devices descend from it. It has been recalled 13 times.
- Decided
- Mar 13, 2006
- Review
- 110 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 13
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002212 (2000). 5 ancestors in all, the oldest K913074 (1991). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 2 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 1 generation backK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · Recalled
- This deviceK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006
- Descendant · cites it directly · 6 of its ownK202522 Synchro SELECT GuidewireStryker Neurovascular · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK243756 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · 3 generations on · 3 of its ownK253168 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · 4 generations on · 1 of its ownK260130 Willow 18 GuidewireArbor Endovascular, LLC · 2026
- Descendant · cites it directly · 1 of its ownK190843 Synchro2 Support GuidewireStryker · 2019 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K202522Synchro SELECT GuidewireStryker Neurovascular · 2020 · cites it directly6descendants
- K2437560.014” Willow GuidewireArbor Endovascular, LLC · 2025 · 2 generations on4descendants
- K2531680.014” Willow GuidewireArbor Endovascular, LLC · 2025 · 3 generations on3descendants
- K260130Willow 18 GuidewireArbor Endovascular, LLC · 2026 · 4 generations on1descendant
- K190843Synchro2 Support GuidewireStryker · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −2 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −1 | K050964 | PV 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | 2005 | 6 |
| 0 (this device) | K053268 | PVS 2000 SYNCHRO2 Guidewire | Boston Scientific - Precision Vascular | 2006 | — |
| +1 | K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020 | 1 |
| +2 | K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +3 | K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +4 | K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026 | — |
| +1 | K190843 | Synchro2 Support Guidewire | Stryker | 2019 | 8 |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | 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 August 2003 DQX Devices SynchroTM .010" Precision Vascular K032146, 12 August 2003 D… | 2003 |
| * | K050964 | PV 1900 Synchro 0.016 GuidewireSummary page 1…Devices SynchroTM .010" Precision Vascular K032146, 12 August 2003 DQX Synchram'.016" Precision Vascular K050964. 13 June 2005 DQX Transend Target Therapeutics K971254, 01 July 1997* D… | 2005 |
| * | K971254 | Transend EX Platinum GuidewireSummary page 1…Synchram'.016" Precision Vascular K050964. 13 June 2005 DQX Transend Target Therapeutics K971254, 01 July 1997* DQX *This information is assumed based upon our best knowledge. Classification… | 1997 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2024 | Class II | Z-1941-2024 | Component design/selection | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is… |
| Jun 7, 2010 | Not classified | Z-0871-2011 | 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-0874-2011 | 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-0869-2011 | 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-0870-2011 | 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-0872-2011 | 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-0873-2011 | 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-0868-2011 | 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-0875-2011 | 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 3, 2010 | Not classified | Z-2069-2010 | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is… |
| Jun 3, 2010 | Not classified | Z-2070-2010 | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is… |
| Jun 3, 2010 | Not classified | Z-2071-2010 | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is… |
| Jun 3, 2010 | Not classified | Z-2068-2010 | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is… |
The 5 latest of 13 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 6 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K202522 (Stryker Neurovascular, 2020) has gone furthest, with 6 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 2000 Synchro®2 Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device 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/K053268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053268: PVS 2000 SYNCHRO2 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053268
Report an extraction error
Are you the manufacturer?
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