510(k) · Cleared
ClearedCoronary Sinus Visualization System, Model CSVS5508
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumen Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 28, 2004 as substantially equivalent to K032622 (Medtronic Vascular, 2003) and 3 other predicates after a 118-day review. Its family tree reaches back 6 generations to 1989. 3 later devices descend from it.
- Decided
- Dec 28, 2004
- Review
- 118 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K893658 (1989). 47 ancestors in all, the oldest K760385 (1976). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 4 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 3 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 2 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 1 generation backK032622 Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular · 2003
- This deviceK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK070051 Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK062340 Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005 · cites it directly1descendant
- K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007 · cites it directly0descendants
- K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −5 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −4 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −3 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −2 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −1 | K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | Medtronic Vascular | 2003 | — |
| 0 (this device) | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| +1 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| +1 | K070051 | Acumen Insight Endocardial Visualization System | Acumen Medical, Inc. | 2007 | — |
| +2 | K062340 | Cardiooptics Augmentative Cardiac Optical Imaging System | Cardio-Optics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYSSummary page 1…svenous devices to the coronary sinus and coronary vasculature of the heart. Predicate Devices AttainT mPrevail® Left Heart Delivery System K032622 Manufactured by Medtronic Inc. VueportTm Coronary Sinus Balloon Occlusion Guiding Catheter K973298 Manufactured by… | 2003 |
| * | K973298 | Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterSummary page 1…Left Heart Delivery System K032622 Manufactured by Medtronic Inc. VueportTm Coronary Sinus Balloon Occlusion Guiding Catheter K973298 Manufactured by Cardimia Inc. T m Coronary Angioscope IrnagCath'… | 1998 |
| * | K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the…Summary page 1…ng Catheter K973298 Manufactured by Cardimia Inc. T m Coronary Angioscope IrnagCath' K952638 Manufactured by Baxter Healthcarc Corp. CCD Solid State Video Camera K855529 Manufa… | 1995 |
| Kept off the family tree | K855529 | CCD Solid State Video Camera Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…K952638 Manufactured by Baxter Healthcarc Corp. CCD Solid State Video Camera K855529 Manufactured by Medical Dynamics., Inc. Battery Plowered Endoscopic Light Source K960081 Manufa… | |
| * | K960081 | Battery Powered Endosccopic Light SourceSummary page 1…a K855529 Manufactured by Medical Dynamics., Inc. Battery Plowered Endoscopic Light Source K960081 Manufactured by Mitsubishi Cable America Inc. Device Description The Acumen Coronary Sinus Visualization System (… | 1996 |
What descends from it? (3)
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 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 47 ancestors have a recall of any class.
- Of its descendants, K050808 (Cardio-Optics, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K032622.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042381: Coronary Sinus Visualization System, Model CSVS5508.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042381
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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