510(k) · Cleared

Cleared

Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models SRCO14MIB, DIISRCO14MIB

K001565510(k) TraditionalCleared Aug 10, 200083-day reviewClass II21 CFR 870.4210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edwards Lifesciences, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Aug 10, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Aug 10, 2000
Review: 83 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK001565 Steerable Retrograde Cardioplegia Cannula with and Without Duraflo…Edwards Lifesciences, LLC · 2000
Descendant · cites it directly · 0 of its ownK123187 Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde…Edwards Lifesciences, LLC · 2013
Descendant · cites it directly · 0 of its ownK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009

Most influential descendants

Showing 2 of 2 · See all

K123187Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter…Edwards Lifesciences, LLC · 2013 · cites it directly0descendants
K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001565	Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment…	Edwards Lifesciences, LLC	2000	—
+1	K123187	Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia…	Edwards Lifesciences, LLC	2013	—
+1	K090869	Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate…	Medtronic Perfusion Systems	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2013	1	0

FIG. 1 — Lineage of K001565, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K123187	Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter…	Edwards Lifesciences, LLC	2013	0
K090869	Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…	Medtronic Perfusion Systems	2009	0

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?

Of its descendants, K123187 (Edwards Lifesciences, LLC, 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007high 1,020 (2025) · low 99 (2009)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	—

https://510kreport.com/device/K001565 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001565: Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models SRCO14MIB, DIISRCO14MIB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001565

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026