510(k) · Cleared

Cleared

Cardiacassist Transseptal Cannula Set, Model 5132-6221

K030398510(k) TraditionalCleared May 23, 2003106-day reviewClass II21 CFR 870.1300

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

Cardiacassist, Inc. · DQR Cannula, Catheter

Cleared on May 23, 2003 as substantially equivalent to K854511 (Electro-Catheter Corp., 1986) after a 106-day review. Its family tree reaches back 1 generation to 1986. 2 of the 12 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided: May 23, 2003
Review: 106 days
Class: Class II
Product code: DQR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K854511 (1986). 10 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK854511 Elecath Percutaneous Left Atrial Cannulation SetElectro-Catheter Corp. · 1986
This deviceK030398 Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003
Descendant · cites it directly · 9 of its ownK052570 Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · Recalled
Descendant · 2 generations on · 7 of its ownK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
Descendant · 3 generations on · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
Descendant · 4 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Descendant · 3 generations on · 1 of its ownK093801 Impella ControllerAbiomed, Inc. · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 2 (2008) · low 0 (2007)2026

Class I recalls in this family

K102726 Cardiohelp System4 generations on · 2011
K133598 Cardiohelp System5 generations on · 2014

Most influential descendants

Showing 5 of 10 · See all

K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · cites it directly9descendants
K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008 · 2 generations on7descendants
K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 3 generations on3descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on2descendants
K093801Impella ControllerAbiomed, Inc. · 2010 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854511	Elecath Percutaneous Left Atrial Cannulation Set	Electro-Catheter Corp.	1986	—
0 (this device)	K030398	Cardiacassist Transseptal Cannula Set, Model 5132-6221	Cardiacassist, Inc.	2003	—
+1	K052570	Tandemheart Transseptal Cannula Set-EF, Model 5140-6221	Cardiacassist, Inc.	2006	1
+2	K063723	Impella Recover LP 2.5 Percutaneous Cardiac Support System	Abiomed, Inc.	2008	—
+3	K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	1
+4	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+3	K093801	Impella Controller	Abiomed, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	1
2012	1	0
2013	1	0
2014	1	1

FIG. 1 — Lineage of K030398, 1986–2014Source: 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K854511	Elecath Percutaneous Left Atrial Cannulation Set Summary page 1 …sist-Transseptal Cannula Set Common Name: Transseptal Cannula Classification Name: Catheter Cannula Predicate Device Elecath Percutaneous Left Atrial Cannulation Set (K8545 11) Device Description The Transseptal Cannula Set consists of three components: (1) 2 1 Fr. Transseptal Cannula, (2) -…	Electro-Catheter Corp.	1986	—

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K052570	Tandemheart Transseptal Cannula Set-EF, Model 5140-6221	Cardiacassist, Inc.	2006	9
K082425	Tandemheart Transseptal Cannula- EF 72	Cardiacassist, Inc.	2008	0

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 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K052570 (Cardiacassist, Inc., 2006) has gone furthest, with 9 descendants of its own.

How does its category compare?

All DQR devices

DQR Cannula, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQR

1in 2013

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQR

Too few DQR 510(k)s in any year since 2007 to give a median.

Recalls per year · DQR

1in 2020

2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQR

6in 2025

2007high 75 (2016) · low 4 (2020)2025

MAUDE reports naming product code DQR, 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	0	—	0	17
2008	1	—	0	8
2009	0	—	0	27
2010	0	—	0	24
2011	0	—	0	7
2012	0	—	0	7
2013	1	—	0	6
2014	0	—	0	8
2015	0	—	0	40
2016	0	—	0	75
2017	0	—	0	29
2018	0	—	0	17
2019	0	—	0	16
2020	0	—	1	4
2021	0	—	0	11
2022	0	—	0	27
2023	0	—	0	36
2024	0	—	0	7
2025	0	—	0	6
2026	0	—	0	—

What is it indicated for?

The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030398: Cardiacassist Transseptal Cannula Set, Model 5132-6221.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030398

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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