510(k) · Cleared
ClearedCardiosolutions Dexterity Steerable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiosolutions, Inc. · DYB Introducer, Catheter
Cleared on Feb 5, 2014 as substantially equivalent to K120086 (Cardiosolutions, 2012) and 1 other predicate after a 34-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Feb 5, 2014
- Review
- 34 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K002054 (2001). 15 ancestors in all, the oldest K964518 (1997). No later device cites it as a predicate yet.
- Root · 9 generations backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
- 5 generations between
- 3 generations backK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
- 2 generations backK120086 Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions…Cardiosolutions · 2012
- 1 generation backK131332 Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc. · 2013
- This deviceK140015 Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc. · 2014
Show all 9 generations
- Root · 9 generations backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
- 8 generations backK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
- 7 generations backK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
- 6 generations backK083793 Steerable Guide CatheterEvalve, Inc. · 2009
- 5 generations backK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
- 4 generations backK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010
- 3 generations backK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
- 2 generations backK120086 Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions…Cardiosolutions · 2012
- 1 generation backK131332 Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc. · 2013
- This deviceK140015 Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K002054 | X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90… | Appriva Medical, Inc. | 2001 | — |
| −8 | K012489 | Modification to: X-Sept Transseptal Shealth and Transition Catheter (with… | Appriva Medical, Inc. | 2001 | — |
| −7 | K043084 | Premere Delivery Sheath, Model PDS | Velocimed, Inc. | 2005 | — |
| −6 | K083793 | Steerable Guide Catheter | Evalve, Inc. | 2009 | — |
| −5 | K091596 | Evalve Steerable Guide Catheter, Model SGC01ST | Evalve, Inc. | 2009 | — |
| −4 | K093866 | Evalve Steerable Guide Catheter | Evalve, Inc. | 2010 | — |
| −3 | K100789 | Modificaton to: Steerable Guide Catheter, Model SGC01ST | Evalve, Inc. | 2010 | — |
| −2 | K120086 | Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro… | Cardiosolutions | 2012 | — |
| −1 | K131332 | Cardiosolutions Percu-Pro Steerable Introducer | Cardiosolutions, Inc. | 2013 | — |
| 0 (this device) | K140015 | Cardiosolutions Dexterity Steerable Introducer | Cardiosolutions, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K120086 | Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Summary page 2…ER 870.1340 Class 2 Panel Cardiovascular Predicate Percu-ProTM Steerable Introducer K 120086, 131332 Devices Device The Cardiosolutions DexterityTM Steerable Introducer is provided as… | 2012 |
| * | K131332 | Cardiosolutions Percu-Pro Steerable IntroducerSummary page 2…0 Class 2 Panel Cardiovascular Predicate Percu-ProTM Steerable Introducer K 120086, 131332 Devices Device The Cardiosolutions DexterityTM Steerable Introducer is provided as a 9Fr a… | 2013 |
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 13 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 3 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K120086.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 DexterityTM Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial 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/K140015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140015: Cardiosolutions Dexterity 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/K140015
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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