510(k) · Cleared
ClearedAcross Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
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 Jun 5, 2007 as substantially equivalent to K052644 (St Jude Medical, 2005) after a 113-day review. Its family tree reaches back 3 generations to 1997. 11 later devices descend from it.
- Decided
- Jun 5, 2007
- Review
- 113 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964518 (1997). 4 ancestors in all. 11 later devices descend from it, 3 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 deviceK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
- Descendant · cites it directly · 8 of its ownK072278 BRK Transseptal NeedleSt Jude Medical · 2007
- Descendant · 2 generations on · 6 of its ownK122587 BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207…St Jude Medical · 2013
- Descendant · 3 generations on · 1 of its ownK172950 TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK172934 Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC · 2018
- Descendant · 4 generations on · 0 of its ownK241042 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072278BRK Transseptal NeedleSt Jude Medical · 2007 · cites it directly8descendants
- K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical · 2013 · 2 generations on6descendants
- K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC · 2018 · 3 generations on1descendant
- K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC · 2018 · 3 generations on1descendant
- K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC · 2024 · 4 generations on0descendants
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) | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… | St Jude Medical | 2007 | — |
| +1 | K072278 | BRK Transseptal Needle | St Jude Medical | 2007 | — |
| +2 | K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | 2013 | — |
| +3 | K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | 2018 | — |
| +3 | K172934 | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | 2018 | — |
| +4 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | 2024 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052644 | Swartz Braided Transseptal Guiding IntroducerSummary page 1…Class 11,21 CFR 870.1340, Product Code DYB Predicate Device: I. St. Jude Medical SwartzT M Braided Transseptal Guiding Introducer (K052644) 2. Thomas Medical Products, Inc. Transseptal Needle (KG 11727) Device Description: The St. Jude Medical ACrossTM Tran… | 2005 |
| Kept off the family tree | K071727 | FDA’s K071727 is QXT Extraction Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K072278 (St Jude Medical, 2007) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K052644.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 St. Jude Medical ACrossTM Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070417
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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