510(k) · Cleared
ClearedFast-Cath Hemostasis Introducer and Transseptal Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DYB Introducer, Catheter
Cleared on Aug 3, 2006 as substantially equivalent to K982187 (Daig Corp., 1998) and 3 other predicates after a 112-day review. Its family tree reaches back 3 generations to 1997. 9 later devices descend from it.
- Decided
- Aug 3, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K964518 (1997). 5 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 2 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 1 generation backK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- This deviceK061015 Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006
- Descendant · cites it directly · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 5 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · cites it directly8descendants
- K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 2 generations on7descendants
- K151951Destino ReachOscor, Inc. · 2015 · 3 generations on6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on5descendants
- K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −2 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −1 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| 0 (this device) | K061015 | Fast-Cath Hemostasis Introducer and Transseptal Introducer | St Jude Medical | 2006 | — |
| +1 | K101497 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2010 | 30 |
| +2 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +3 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +4 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +5 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K982187 | Fast-Cath Intra-Cardiac IntroducerSummary page 1…Product Code: DYB Predicate Devices: Fast-Cath Intracardiac Introducer K982187, K973840 Fast-Cath Transseptal Introducer K0526… | 1998 |
| * | K973840 | Fast-Cath (TM) Intra-Cardiac IntroducerSummary page 1…Product Code: DYB Predicate Devices: Fast-Cath Intracardiac Introducer K982187, K973840 Fast-Cath Transseptal Introducer K052644… | 1998 |
| * | K052644 | Swartz Braided Transseptal Guiding IntroducerSummary page 1…K982187, K973840 Fast-Cath Transseptal Introducer K052644 Fast-Cath Transseptal Catheter Introducer K9645… | 2005 |
| * | K964518 | Fast-Cath Transseptal Catheter IntroducerSummary page 1…K052644 Fast-Cath Transseptal Catheter Introducer K964518 Device Description Both the Fast-Cath hemostasis and transseptal introducers are used for introducing various catheters into the… | 1997 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101497 | Delivery Sheath, Model Adelante Breezeway | 2010 | 8 |
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 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K101497 (Oscor, Inc., 2010) has gone furthest, with 8 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 Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061015: Fast-Cath Hemostasis Introducer and Transseptal Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061015
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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