510(k) · Cleared

Cleared

Remote Access Perfusion Cannula Left Axillary 21 French

K032632510(k) AbbreviatedCleared Oct 22, 200357-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

Estech, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Oct 22, 2003 as substantially equivalent to K990573 (Estech, Inc., 1999) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1999. 2 of the 7 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.

Decided: Oct 22, 2003
Review: 57 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K990573 (1999). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK990573 Estech Arterial Remote Access Perfusion CannulaEstech, Inc. · 1999
This deviceK032632 Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc. · 2003
Descendant · cites it directly · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013

Class I recalls in this family

K102726 Cardiohelp System2 generations on · 2011
K133598 Cardiohelp System3 generations on · 2014

Most influential descendants

Showing 4 of 4 · See all

K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · cites it directly3descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on0descendants
K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990573	Estech Arterial Remote Access Perfusion Cannula	Estech, Inc.	1999	—
0 (this device)	K032632	Remote Access Perfusion Cannula Left Axillary 21 French	Estech, Inc.	2003	—
+1	K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	1
+2	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+3	K133598	Cardiohelp System	Maquet Cardiopulmonary, AG	2014	Class I
+3	K133265	Quadrox-IR Adult and Small Adult	Maquet Cardiopulmonary, AG	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	1
2013	1	0
2014	1	1

FIG. 1 — Lineage of K032632, 1999–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. 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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K990573	Estech Arterial Remote Access Perfusion Cannula Summary page 1 …sion Cannula Cannula Manufacturer: ESTECH Edwards Lifesciences 5 1O(k) Number: K990573 KO02578 Substantial Equivalence 1999-03-1 1 2002-04- 1 1 De…	Estech, Inc.	1999	—
*	K002578	Axillary Access Arterial Cannula	Edwards Lifesciences, LLC	2002	—

Also cleared against K990573: 2 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	3

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K083111 (Abiomed, Inc., 2009) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K990573.

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	—

What is it indicated for?

The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (< 6 hours). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032632 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032632: Remote Access Perfusion Cannula Left Axillary 21 French.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032632

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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