510(k) · Cleared
ClearedCPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Cardiac Rhythm Management Divisi · DQY Catheter, Percutaneous
Cleared on Aug 7, 2009 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 7, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK092075 CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002…St. Jude Medical, Cardiac Rhythm Management Divisi · 2009
- Descendant · cites it directly · 1 of its ownK130257 CPS Direct Universal Slittable Outer CatheterSt Jude Medical · 2013
- Descendant · cites it directly · 1 of its ownK120296 CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- Descendant · 2 generations on · 0 of its ownK231311 CPS Direct™ Universal slittable outer guide catheter (DS2C029)Abbott Medical · 2023
- Descendant · 2 generations on · 0 of its ownK142239 CPS Direct MediGuide Enabled outer catheterSt Jude Medical · 2014
Most influential descendants
Showing 4 of 4 · See all- K130257CPS Direct Universal Slittable Outer CatheterSt Jude Medical · 2013 · cites it directly1descendant
- K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012 · cites it directly1descendant
- K231311CPS Direct™ Universal slittable outer guide catheter (DS2C029)Abbott Medical · 2023 · 2 generations on0descendants
- K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092075 | CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003… | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009 | — |
| +1 | K130257 | CPS Direct Universal Slittable Outer Catheter | St Jude Medical | 2013 | — |
| +1 | K120296 | CPS Direct Mediguide Enabled Outer Catheter | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| +2 | K231311 | CPS Direct™ Universal slittable outer guide catheter (DS2C029) | Abbott Medical | 2023 | — |
| +2 | K142239 | CPS Direct MediGuide Enabled outer catheter | St Jude Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K130257 (St Jude Medical, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092075: CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092075
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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