510(k) · Cleared
Recalled · 2006Agilis Steerable Catheter Introducer, Model 408304
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Daig Division, Inc. · DYB Introducer, Catheter
Cleared on Jan 27, 2005 as substantially equivalent to K964518 (Daig Corp., 1997) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1997. 2 of the 84 devices in its family, counting itself, have a Class I recall. 81 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 2005
- Review
- 122 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964518 (1997). 2 ancestors in all. 81 later devices descend from it, 4 citing it directly. 2 of the 84 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- This deviceK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005
- Descendant · cites it directly · 53 of its ownK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- Descendant · 2 generations on · 36 of its ownK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- Descendant · cites it directly · 36 of its ownK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- Descendant · 2 generations on · 11 of its ownK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
- Descendant · 2 generations on · 9 of its ownK061015 Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 81 · See all- K061363Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · cites it directly53descendants
- K081645Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008 · 2 generations on36descendants
- K052644Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005 · cites it directly36descendants
- K070417Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…St Jude Medical · 2007 · 2 generations on11descendants
- K061015Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| 0 (this device) | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | — |
| +1 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| +2 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| +1 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| +2 | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… | St Jude Medical | 2007 | — |
| +2 | K061015 | Fast-Cath Hemostasis Introducer and Transseptal Introducer | St Jude Medical | 2006 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 1 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 1 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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.
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 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
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 | Decided |
|---|---|---|---|
| * | K964518 | Fast-Cath Transseptal Catheter IntroducerSummary page 1…0) Predicate Devices: Fast-CathlM (Two-Piece AMAS) Transseptal & Intra- Cardiac Catheter Introducers (1K964518 & K973840) Device Description: The AgilJiST M Steerable Catheter Introducer set consists… | 1997 |
| * | K973840 | Fast-Cath (TM) Intra-Cardiac IntroducerSummary page 1…Predicate Devices: Fast-CathlM (Two-Piece AMAS) Transseptal & Intra- Cardiac Catheter Introducers (1K964518 & K973840) Device Description: The AgilJiST M Steerable Catheter Introducer set consists… | 1998 |
What descends from it? (81)
See all 814 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2006 | Not classified | Z-1086-06 | Other | St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of… |
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.
What does this lineage say?
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 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 (SJM) Agilis TM Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septurn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042623: Agilis Steerable Catheter Introducer, Model 408304.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042623
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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