510(k) · Cleared
Recalled · Class II · 2020Flextra Steerable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhythm Xience, Inc. (Rxi) · DYB Introducer, Catheter
Cleared on Feb 27, 2017 as substantially equivalent to K061363 (St Jude Medical, 2006) after a 20-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 27, 2017
- Review
- 20 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964518 (1997). 5 ancestors in all. 4 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 backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- This deviceK170373 Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi) · 2017
- Descendant · cites it directly · 3 of its ownK193509 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK210685 AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK233691 FlexCath Cross Transseptal SolutionAcutus Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK220047 AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc. · 2020 · cites it directly3descendants
- K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2021 · 2 generations on2descendants
- K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc. · 2023 · 3 generations on0descendants
- K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2022 · 3 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 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| 0 (this device) | K170373 | Flextra Steerable Introducer | Rhythm Xience, Inc. (Rxi) | 2017 | — |
| +1 | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | Acutus Medical, Inc. | 2020 | — |
| +2 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2021 | — |
| +3 | K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | 2023 | — |
| +3 | K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K061363 | Agilis NXT Steerable IntroducerSummary page 4…iovascular The RXI Flextra Steerable Introducer is substantially equivalent to the previously cleared predicate, St. Jude Medical (SJM) Agilis™ NxT Steerable Introducer, K061363. Table 5.3 Predicate Device Predicate Device Manufacture… | 2006 |
| † | K072278 | BRK Transseptal Needle | 2007 |
| † | K032050 | Perivac Kit | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2020 | Class II | Z-1769-2020 | Process design | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. |
| Feb 25, 2020 | Class II | Z-1768-2020 | Process design | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. |
| Feb 25, 2020 | Class II | Z-1771-2020 | Process design | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. |
| Feb 25, 2020 | Class II | Z-1770-2020 | Process design | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K193509 (Acutus Medical, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 14 other devices also cite its predicate K061363.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Flextra™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
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/K170373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170373: Flextra Steerable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170373
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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