510(k) · Cleared
Recalled · Class III · 2012Fast-Cath Transseptal Catheter Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daig Corp. · DYB Introducer, Catheter
Cleared on May 14, 1997 after a 201-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 93 devices in its family, counting itself, have a Class I recall. 92 later devices descend from it. It has been recalled 4 times.
- Decided
- May 14, 1997
- Review
- 201 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 4
- Predicates
- 0
92 later devices descend from it, 9 citing it directly. 2 of the 93 devices in this family, counting this one, have a Class I recall.
- This deviceK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997
- Descendant · cites it directly · 81 of its ownK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 53 of its ownK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- Descendant · 3 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 · cites it directly · 13 of its ownK022067 Convoy Advanced Delivery SheathBoston Scientific · 2002 · Recalled
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 92 · See all- K042623Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · cites it directly81descendants
- K061363Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · 2 generations on53descendants
- K081645Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008 · 3 generations on36descendants
- K052644Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005 · cites it directly36descendants
- K022067Convoy Advanced Delivery SheathBoston Scientific · 2002 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | — |
| +1 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| +2 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| +3 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| +1 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| +1 | K022067 | Convoy Advanced Delivery Sheath | Boston Scientific | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 1 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 1 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 0 |
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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (92)
See all 929 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042623 | Agilis Steerable Catheter Introducer, Model 408304 | 2005 | 81 |
| K052644 | Swartz Braided Transseptal Guiding Introducer | 2005 | 36 |
| K022067 | Convoy Advanced Delivery Sheath | 2002 | 13 |
| K061015 | Fast-Cath Hemostasis Introducer and Transseptal Introducer | 2006 | 9 |
| K043084 | Premere Delivery Sheath, Model PDS | 2005 | 9 |
| K212626 | PathBuilder Transseptal Guiding Introducer | 2022 | 0 |
| K181031 | TSI Transseptal Introducer | 2018 | 0 |
| K040552 | Model 3100 Series Sheath Introducer Kits, Models 3110, 3130 | 2004 | 0 |
| K983940 | EZ-Intro Percutaneous Catheter Sheath, EZ-Intro Vessel Dilator | 1999 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2012 | Class III | Z-0617-2013 | Process control | St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling. |
| Oct 5, 2006 | Not classified | Z-0535-2007 | Other | Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied. |
| Aug 4, 2004 | Not classified | Z-1426-04 | Other | St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated… |
| Aug 4, 2004 | Not classified | Z-1425-04 | Other | St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated… |
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?
- Of its descendants, K042623 (St. Jude Medical, Daig Division, Inc., 2005) has gone furthest, with 81 descendants of its own.
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) | — |
https://510kreport.com/device/K964518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964518: Fast-Cath Transseptal Catheter Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964518
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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