510(k) · Cleared
ClearedCariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiosolutions · DRA Catheter, Steerable
Cleared on Apr 24, 2012 as substantially equivalent to K042623 (St. Jude Medical, Daig Division, Inc., 2005) and 1 other predicate after a 104-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it.
- Decided
- Apr 24, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K002054 (2001). 13 ancestors in all, the oldest K964518 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
- 6 generations backK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
- 5 generations backK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
- 4 generations backK083793 Steerable Guide CatheterEvalve, Inc. · 2009
- 3 generations backK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
- 2 generations backK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010
- 1 generation backK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
- This deviceK120086 Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions…Cardiosolutions · 2012
- Descendant · cites it directly · 1 of its ownK131332 Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140015 Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002054 | X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90… | Appriva Medical, Inc. | 2001 | — |
| −6 | K012489 | Modification to: X-Sept Transseptal Shealth and Transition Catheter (with… | Appriva Medical, Inc. | 2001 | — |
| −5 | K043084 | Premere Delivery Sheath, Model PDS | Velocimed, Inc. | 2005 | — |
| −4 | K083793 | Steerable Guide Catheter | Evalve, Inc. | 2009 | — |
| −3 | K091596 | Evalve Steerable Guide Catheter, Model SGC01ST | Evalve, Inc. | 2009 | — |
| −2 | K093866 | Evalve Steerable Guide Catheter | Evalve, Inc. | 2010 | — |
| −1 | K100789 | Modificaton to: Steerable Guide Catheter, Model SGC01ST | Evalve, Inc. | 2010 | — |
| 0 (this device) | K120086 | Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro… | Cardiosolutions | 2012 | — |
| +1 | K131332 | Cardiosolutions Percu-Pro Steerable Introducer | Cardiosolutions, Inc. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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 |
|---|---|---|---|
| * | K042623 | Agilis Steerable Catheter Introducer, Model 408304Summary page 1…21 CFR 870.1280 Class 2 Panel Cardiovascular Predicate St. Jude Medical, Diag Division, Inc., AgiliSTM Steerable Catheter Introducer, K042623 Devices Evalve Inc., Steerable Guide Catheter, K100789 Device The Cardiosolutions Percu-ProTM Steerable Intro… | 2005 |
| * | K100789 | Modificaton to: Steerable Guide Catheter, Model SGC01STSummary page 1…vascular Predicate St. Jude Medical, Diag Division, Inc., AgiliSTM Steerable Catheter Introducer, K042623 Devices Evalve Inc., Steerable Guide Catheter, K100789 Device The Cardiosolutions Percu-ProTM Steerable Introducer is a 141'r Introducer. The set Description also consi… | 2010 |
What descends from it? (2)
2 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 11 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K131332 (Cardiosolutions, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K042623.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Percu-ProTM Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120086
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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