510(k) · Cleared
ClearedPVS 1400 Guidewire
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 Jul 23, 1999 as substantially equivalent to K881897 (Advanced Cardiovascular Systems, Inc., 1988) and 3 other predicates after a 133-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jul 23, 1999
- Review
- 133 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K873543 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK873543 Stubbie Steerable GuidewireTarget Therapeutics · 1987
- This deviceK990823 PVS 1400 GuidewirePrecision Vascular Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873543 | Stubbie Steerable Guidewire | Target Therapeutics | 1987 | — |
| 0 (this device) | K990823 | PVS 1400 Guidewire | Precision Vascular Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K881897 | Acs HI-Torque Floppy/Floppy II/Inter./Standard GWSummary page 2…vely: Please see Appendix I. Intra-operatively: Please see Appendix [. Post-operatively: Please see Appendix I. Equivalent/Predicate Devices: ACS Hi-Torque Floppy II® (K881897), Microvena UltraSelect® Nitinol Guidewire (K910280) Standard and Floppy Tip, Boston Scientific/Medi-Tech Target Stubbie® (K87354… | 1988 |
| * | K910280 | Ultra-Select Ptca GuidewireSummary page 2…se see Appendix [. Post-operatively: Please see Appendix I. Equivalent/Predicate Devices: ACS Hi-Torque Floppy II® (K881897), Microvena UltraSelect® Nitinol Guidewire (K910280) Standard and Floppy Tip, Boston Scientific/Medi-Tech Target Stubbie® (K873543), and Cordis Corp. Wizdom® (K953760). Device Desc… | 1991 |
| * | K873543 | Stubbie Steerable GuidewireSummary page 2…te Devices: ACS Hi-Torque Floppy II® (K881897), Microvena UltraSelect® Nitinol Guidewire (K910280) Standard and Floppy Tip, Boston Scientific/Medi-Tech Target Stubbie® (K873543), and Cordis Corp. Wizdom® (K953760). Device Description: These guidewires are intended for use in percutaneous procedures to i… | 1987 |
| * | K953760 | Cordis Wizdom Steerable GuidewireSummary page 2…® (K881897), Microvena UltraSelect® Nitinol Guidewire (K910280) Standard and Floppy Tip, Boston Scientific/Medi-Tech Target Stubbie® (K873543), and Cordis Corp. Wizdom® (K953760). Device Description: These guidewires are intended for use in percutaneous procedures to introduce and position catheters and… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K881897.
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?
These guidewires are intended for use in percutaneous procedures to introduce and
position catheters and other interventional devices within the coronary and peripheral
vasculature
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990823: PVS 1400 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990823
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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