510(k) · Cleared
Recalled · Class II · 2014Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic Perfusion Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 11, 2012 as substantially equivalent to K831769 (Research Industries Corp., 1983) after a 206-day review. Its family tree reaches back 1 generation to 1983. It has been recalled once.
- Decided
- Jun 11, 2012
- Review
- 206 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831769 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983 · Recalled
- This deviceK113411 Edward Vent Catheters Edward Vent Catheters with Duraflo Coating…Edwards Lifesciences, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831769 | Various Cardiovascular Surgical Device | Research Industries Corp. | 1983 | 8 |
| 0 (this device) | K113411 | Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion… | Edwards Lifesciences, LLC | 2012 | — |
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 |
|---|---|---|---|
| * | K831769 | Various Cardiovascular Surgical DeviceSummary page 1…ation Name: cardiopulmonary bypass vascular catheter, cannula or tubing Class 11 (21 CFR §870.4210). Predicate Device: K831 769 - Various Cardiovascular Surgical Devices - Vent Catheters Device Description: Edwards Lifescience… | 1983 |
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 |
|---|---|---|---|---|
| Oct 8, 2014 | Class II | Z-0217-2015 | Device Design | Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K831769.
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. 2012, 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?
Atrial Vent Catheters are intended for venting the left heart during short-term (<6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle.
Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term (<6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle.
Extracorporeal circuit components with a Duraflo® coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113411: Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic Perfusion Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113411
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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