510(k) · Cleared
Recalled · Class II · 2026AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 18, 2018 as substantially equivalent to K161596 (AngioDynamics, Inc., 2017) after a 219-day review. Its family tree reaches back 3 generations to 2012. It has been recalled 18 times.
- Decided
- Jul 18, 2018
- Review
- 219 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 18
- Predicates
- 1
Its longest line of descent runs back 3 generations to K112452 (2012). No later device cites it as a predicate yet.
- Root · 3 generations backK112452 Angiodynamics Soft-VU Angiographic CathetersAngioDynamics, Inc. · 2012 · Recalled
- 2 generations backK151724 AngioDynamics Mariner Angiographic CathetersAngioDynamics, Inc. · 2015
- 1 generation backK161596 Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersAngioDynamics, Inc. · 2017 · Recalled
- This deviceK173762 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K112452 | Angiodynamics Soft-VU Angiographic Catheters | AngioDynamics, Inc. | 2012 | 20 |
| −2 | K151724 | AngioDynamics Mariner Angiographic Catheters | AngioDynamics, Inc. | 2015 | — |
| −1 | K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | AngioDynamics, Inc. | 2017 | 20 |
| 0 (this device) | K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | AngioDynamics, Inc. | 2018 | — |
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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersSummary page 4…nostic (21CFR§870.1200, Class II, Pro-Code DQO) Classification Panel: Cardiovascular Premarket Notification: K161596 K173762… | 2017 |
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 |
|---|---|---|---|---|
| Mar 3, 2026 | Class II | Z-1861-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1859-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1866-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1864-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1868-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1863-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1867-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1858-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1856-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1871-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1860-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1862-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1869-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1857-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1870-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Mar 3, 2026 | Class II | Z-1865-2026 | Nonconforming Material/Component | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. |
| Jun 18, 2024 | Class II | Z-2454-2024 | Packaging change control | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) |
| Jun 18, 2024 | Class II | Z-2453-2024 | Packaging change control | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) |
The 5 latest of 18 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 1 company; a new generation was cleared every 1.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173762: AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173762
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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