510(k) · Cleared
ClearedCPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQY Catheter, Percutaneous
Cleared on Dec 18, 2014 as substantially equivalent to K090613 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2009) and 1 other predicate after a 127-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Dec 18, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K934139 (1995). 14 ancestors in all, the oldest K841802 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 4 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 3 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 2 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 1 generation backK091780 Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009
- This deviceK142235 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled…St Jude Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −5 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −4 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −3 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −2 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −1 | K091780 | Guided Measurement Catheter (GMC) | Mediguide, Ltd. | 2009 | — |
| 0 (this device) | K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner… | St Jude Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K090613 | CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59…Summary page 4…e is equivalent to the following St Jude Medical and MediGuide Devices St Jude Medical CPS Aim™ SL Slittable Inner Catheter (K090613) cleared on July 7, 2009 MediGuide Guided Measurement Catheter (GMC) (K091780) clear… | 2009 |
| * | K091780 | Guided Measurement Catheter (GMC)Summary page 4…Medical CPS Aim™ SL Slittable Inner Catheter (K090613) cleared on July 7, 2009 MediGuide Guided Measurement Catheter (GMC) (K091780) cleared on October 16, 2009 Device Description: The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slitta… | 2009 |
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 19 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- None of the 14 ancestors has a recall.
- 1 other device also cites its predicate K090613.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work…
Read the full statement (108 words)
The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142235 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142235: CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142235
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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