510(k) · Cleared
Recalled · Class II · 2017Creganna-Tactx Steerable Sheath Set Symmetric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creganna Medical Devices · DYB Introducer, Catheter
Cleared on Aug 1, 2013 as substantially equivalent to K081645 (St Jude Medical, 2008) and 1 other predicate after a 106-day review. Its family tree reaches back 4 generations to 1997. It has been recalled 4 times.
- Decided
- Aug 1, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964518 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 3 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 2 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 1 generation backK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- This deviceK131079 Creganna-Tactx Steerable Sheath Set SymmetricCreganna Medical Devices · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −3 | 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 |
| −1 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| 0 (this device) | K131079 | Creganna-Tactx Steerable Sheath Set Symmetric | Creganna Medical Devices | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 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? (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 |
|---|---|---|---|
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 1…e head, including the left side of the heart through the interatrial septum. Predicate Device Agilis NxTTM Steerable Introducer K081645, K061363 Manufactured by St. Jude Medical (SJM) Device Description Steerable Sheath The Creganna-Tactx Steerable Sheath is a st… | 2008 |
| * | K061363 | Agilis NXT Steerable IntroducerSummary page 1…ncluding the left side of the heart through the interatrial septum. Predicate Device Agilis NxTTM Steerable Introducer K081645, K061363 Manufactured by St. Jude Medical (SJM) Device Description Steerable Sheath The Creganna-Tactx Steerable Sheath is a stainless s… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2017 | Class II | Z-2530-2017 | Packaging | Lack of sterility assurance. |
| May 22, 2017 | Class II | Z-2532-2017 | Packaging | Lack of sterility assurance. |
| May 22, 2017 | Class II | Z-2531-2017 | Packaging | Lack of sterility assurance. |
| May 22, 2017 | Class II | Z-2529-2017 | Packaging | Lack of sterility assurance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 15 other devices also cite its predicate K081645.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Creganna-Tactx Steerable Sheath Set is indicated when introducing the various cardiovascular catheters into the heart, including the left side of heart through the interatrial septum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131079: Creganna-Tactx Steerable Sheath Set Symmetric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131079
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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