510(k) · Cleared
ClearedAngioVac C20, AngioVac C180
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jul 5, 2019 as substantially equivalent to K142593 (AngioDynamics, Inc., 2014) after a 120-day review. Its family tree reaches back 3 generations to 2009. 2 later devices descend from it.
- Decided
- Jul 5, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091304 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK091304 Vortex CannulaVortex Medical, Inc. · 2009
- 2 generations backK133445 Angiovac CannulaVortex Medical, Inc. · 2014
- 1 generation backK142593 AngioVac CannulaAngioDynamics, Inc. · 2014
- This deviceK190594 AngioVac C20, AngioVac C180AngioDynamics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253106 AngioVac CannulaAngioDynamics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK212386 AngioVac F18 85AngioDynamics, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091304 | Vortex Cannula | Vortex Medical, Inc. | 2009 | — |
| −2 | K133445 | Angiovac Cannula | Vortex Medical, Inc. | 2014 | — |
| −1 | K142593 | AngioVac Cannula | AngioDynamics, Inc. | 2014 | — |
| 0 (this device) | K190594 | AngioVac C20, AngioVac C180 | AngioDynamics, Inc. | 2019 | — |
| +1 | K253106 | AngioVac Cannula | AngioDynamics, Inc. | 2025 | — |
| +1 | K212386 | AngioVac F18 85 | AngioDynamics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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 |
|---|---|---|---|
| * | K142593 | AngioVac CannulaSummary page 4…(21 CFR § 878.4210, Class II, Pro-Code DWF) Classification Panel: Cardiovascular D. PREDICATE DEVICE 510(k): K142593 Trade Name: AngioVac Canula Common/Usual Name: Cardiopulmonary Bypass Venous Cannula Extractio… | 2014 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253106 (AngioDynamics, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190594: AngioVac C20, AngioVac C180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190594
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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