510(k) · Cleared
Recalled · Class II · 2024PVS 1600 Synchro 0.010 Neuro Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Vascular Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Dec 4, 2002 as substantially equivalent to K002907 (Precision Vascular Systems, Inc., 2001) and 3 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Dec 4, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K964611 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964611 Transend GuidewireBoston Scientific Corp · 1997
- This deviceK023700 PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964611 | Transend Guidewire | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K023700 | PVS 1600 Synchro 0.010 Neuro Guide Wire | Precision Vascular Systems, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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? (5)
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 |
|---|---|---|---|
| * | K002907 | PVS 1300 Neuro Guide WireSummary page 1…Code Predicate 1 Devices SynchroTM .OIY I Precision Vascular I K002907,08 March 2001 I DQX Transend-I 0 1 Target Therapeutics I K964611, 02 May 1996*… | 2001 |
| * | K964611 | Transend GuidewireSummary page 1…I K002907,08 March 2001 I DQX Transend-I 0 1 Target Therapeutics I K964611, 02 May 1996* I DQX Agility-I 0 I Cordis 1 K991646,20 Jul2000… | 1997 |
| * | K991646 | Agility Steerable GuidewireSummary page 1…Transend-I 0 1 Target Therapeutics I K964611, 02 May 1996* I DQX Agility-I 0 I Cordis 1 K991646,20 Jul2000 I DQX Miraae .008” 1 Micro TheraDeutics I K002212.03 Aua 2000… | 1999 |
| * | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608Summary page 1…QX Agility-I 0 I Cordis 1 K991646,20 Jul2000 I DQX Miraae .008” 1 Micro TheraDeutics I K002212.03 Aua 2000 I DQX * This information is assumed based on our best, current knowledge. Cla… | 2000 |
| * | — | PVS 1300 Synchro Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-1909-2024 | Process design | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
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 PVS 1600 Synchro@ 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the 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/K023700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023700: PVS 1600 Synchro 0.010 Neuro 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/K023700
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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