510(k) · Cleared
ClearedRetrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia 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 Feb 22, 2013 as substantially equivalent to K880103 (Research Medical, Inc., 1988) and 2 other predicates after a 134-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Feb 22, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K880103 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK880103 Catheter, Cannula and Tubing, Vascular, Cardiopul.Research Medical, Inc. · 1988
- 1 generation backK991170 Retrograde Cardioplegia Cannula with Duraflo Treatment, Model…Edwards Lifesciences Research Medical · 1999
- This deviceK123187 Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde…Edwards Lifesciences, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul. | Research Medical, Inc. | 1988 | — |
| −1 | K991170 | Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014 | Edwards Lifesciences Research Medical | 1999 | — |
| 0 (this device) | K123187 | Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia… | Edwards Lifesciences, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul.Summary page 1…ter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass, 21 CFR Part 870.4210, Product Code DWF, Class II Predicate Device: K880103 - Retrograde Coronary Sinus Cardioplegia Cannulae K991170 - Retrograde Cardioplegia Cannulae with D… | 1988 |
| * | K991170 | Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014Summary page 1…21 CFR Part 870.4210, Product Code DWF, Class II Predicate Device: K880103 - Retrograde Coronary Sinus Cardioplegia Cannulae K991170 - Retrograde Cardioplegia Cannulae with Duraflo Treatment K001 665 -… | 1999 |
| * | K001565 | Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models… Our reading of the summary gave K001665, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Steerable Retrograde Cardioplegia Cannula with and without Duraflo…”. | 2000 |
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K880103.
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. 2013, 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?
Retrograde coronary sinus cardioplegia catheters with and without Duraflo coating are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection.
Retrograde coronary sinus cardioplegia catheters may be used in pediatric or adult populations based on the requirements of individual patient anatomy.
This device is for short-term use only (≤ 6 hours).
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123187: Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123187
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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