510(k) · Cleared
Recalled · 2004Fast-Cath (TM) Intra-Cardiac 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 21, 1998 after a 225-day review. The FDA summary names its predicate without a number. 2 of the 84 devices in its family, counting itself, have a Class I recall. 83 later devices descend from it. It has been recalled 2 times.
- Decided
- May 21, 1998
- Review
- 225 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 0
83 later devices descend from it, 3 citing it directly. 2 of the 84 devices in this family, counting this one, have a Class I recall.
- This deviceK973840 Fast-Cath (TM) Intra-Cardiac IntroducerDaig Corp. · 1998
- 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 · 2 generations on · 36 of its ownK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- Descendant · 3 generations on · 11 of its ownK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 83 · 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 · 2 generations on36descendants
- K070417Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982…St Jude Medical · 2007 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973840 | Fast-Cath (TM) Intra-Cardiac Introducer | Daig Corp. | 1998 | — |
| +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 | — |
| +2 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| +3 | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… | St Jude Medical | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | — | Fast-Cath™ Transseptal Catheter Introducer Named without a submission number |
What descends from it? (83)
See all 833 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 |
|---|---|---|---|---|
| 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) | — |
What is it indicated for?
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when introducing various cardiovascular catheters or biopsy devices into the heart.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973840: Fast-Cath (TM) Intra-Cardiac Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973840
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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