510(k) · Cleared
ClearedFlexCath Cross Transseptal Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acutus Medical, Inc. · DYB Introducer, Catheter
Cleared on Dec 17, 2023 as substantially equivalent to K210685 (Acutus Medical, Inc., 2021) after a 31-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Dec 17, 2023
- Review
- 31 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964518 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 5 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 4 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 3 generations backK170373 Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi) · 2017 · Recalled
- 2 generations backK193509 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc. · 2020
- 1 generation backK210685 AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2021
- This deviceK233691 FlexCath Cross Transseptal SolutionAcutus Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −5 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −4 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| −3 | K170373 | Flextra Steerable Introducer | Rhythm Xience, Inc. (Rxi) | 2017 | 4 |
| −2 | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | Acutus Medical, Inc. | 2020 | — |
| −1 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2021 | — |
| 0 (this device) | K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K210685 | AcQCross Qx Integrated Transseptal Dilator/NeedleSummary page 5…ate Device Manufacturer FDA 510(k) AcQCross™ Qx Integrated Acutus Medical K210685 Transseptal Dilator/Needle Device Description [807.92(a)(4)] FlexCath Cross™ combines the conventional vessel dilator and tra… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K210685.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 FlexCath Cross™ Transseptal Solution is indicated to puncture the interatrial septum to gain
access to the left side of the heart whereby various cardiovascular catheters are introduced.
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/K233691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233691: FlexCath Cross Transseptal Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233691
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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