510(k) · Cleared

Cleared

Swartz Braided Transseptal Guiding Introducer

K052644510(k) SpecialCleared Dec 5, 200570-day reviewClass II21 CFR 870.1340

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

St Jude Medical · DYB Introducer, Catheter

Cleared on Dec 5, 2005 as substantially equivalent to K964518 (Daig Corp., 1997) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1997. 36 later devices descend from it.

Decided: Dec 5, 2005
Review: 70 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K964518 (1997). 3 ancestors in all. 36 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
1 generation backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
This deviceK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
Descendant · cites it directly · 11 of its ownK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
Descendant · cites it directly · 9 of its ownK061015 Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006
Descendant · 2 generations on · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
Descendant · cites it directly · 8 of its ownK083793 Steerable Guide CatheterEvalve, Inc. · 2009
Descendant · 2 generations on · 8 of its ownK072278 BRK Transseptal NeedleSt Jude Medical · 2007

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2006high 3 (2010) · low 0 (2008)2026

Most influential descendants

Showing 5 of 36 · See all

K070417Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…St Jude Medical · 2007 · cites it directly11descendants
K061015Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006 · cites it directly9descendants
K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · 2 generations on8descendants
K083793Steerable Guide CatheterEvalve, Inc. · 2009 · cites it directly8descendants
K072278BRK Transseptal NeedleSt Jude Medical · 2007 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K964518	Fast-Cath Transseptal Catheter Introducer	Daig Corp.	1997	4
−1	K042623	Agilis Steerable Catheter Introducer, Model 408304	St. Jude Medical, Daig Division, Inc.	2005	1
0 (this device)	K052644	Swartz Braided Transseptal Guiding Introducer	St Jude Medical	2005	—
+1	K070417	Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981…	St Jude Medical	2007	—
+1	K061015	Fast-Cath Hemostasis Introducer and Transseptal Introducer	St Jude Medical	2006	—
+2	K101497	Delivery Sheath, Model Adelante Breezeway	Oscor, Inc.	2010	30
+1	K083793	Steerable Guide Catheter	Evalve, Inc.	2009	—
+2	K072278	BRK Transseptal Needle	St Jude Medical	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2009	2	0
2010	3	0
2011	2	0
2012	2	0
2013	2	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0
2018	3	0
2020	2	0
2021	2	0
2022	2	0
2023	1	0
2024	3	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K052644, 1997–2026Source: 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.

Planning a device in DYB? 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 DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 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? (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
*	K964518	Fast-Cath Transseptal Catheter Introducer Summary page 1 …er 21CFR 870.1340) Predicate Devices: Fast-CathTm (Two-Piece AMAS) Transseptal Catheter Introducers (K(964518) AgiliS'TM Steerable Catheter Introducer (K(042623) Device Description:…	Daig Corp.	1997	4
*	K042623	Agilis Steerable Catheter Introducer, Model 408304 Summary page 1 …nsseptal Catheter Introducers (K(964518) AgiliS'TM Steerable Catheter Introducer (K(042623) Device Description: The Swartzlm Braided Transseptal Guiding Introducer…	St. Jude Medical, Daig Division, Inc.	2005	1

Also cleared against K964518: 8 other devices →

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K070417	Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…	St Jude Medical	2007	11
K061015	Fast-Cath Hemostasis Introducer and Transseptal Introducer	St Jude Medical	2006	9
K083793	Steerable Guide Catheter	Evalve, Inc.	2009	8
K171081	Guider Catheter Introducer	Rhythm Xience, Inc. (Rxi)	2017	4

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 8 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
3 of the 3 ancestors have a recall of any class.
Of its descendants, K070417 (St Jude Medical, 2007) has gone furthest, with 11 descendants of its own.
8 other devices also cite its predicate K964518.

How does its category compare?

All DYB devices

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

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

The St. Jude Medical Transseptal Catheter Introducer Set is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052644: Swartz Braided Transseptal Guiding Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052644

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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