510(k) · Cleared
ClearedAttain Prevail Left Heart Delivery System Moddel, 6228SYS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Sep 3, 2003 as substantially equivalent to K031211 (Medtronic Vascular, 2003) and 1 other predicate after an 8-day review. Its family tree reaches back 5 generations to 1989. 5 later devices descend from it.
- Decided
- Sep 3, 2003
- Review
- 8 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K893658 (1989). 42 ancestors in all, the oldest K760385 (1976). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 4 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 3 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 2 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 1 generation backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- This deviceK032622 Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular · 2003
- Descendant · cites it directly · 3 of its ownK042381 Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK082670 Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK070051 Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK062340 Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc. · 2004 · cites it directly3descendants
- K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005 · 2 generations on1descendant
- K082670Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc. · 2008 · cites it directly0descendants
- K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007 · 2 generations on0descendants
- K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −4 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −3 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −2 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −1 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| 0 (this device) | K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | Medtronic Vascular | 2003 | — |
| +1 | K042381 | Coronary Sinus Visualization System, Model CSVS5508 | Acumen Medical, Inc. | 2004 | — |
| +2 | K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | Cardio-Optics, Inc. | 2005 | — |
| +1 | K082670 | Modification to: Attain Prevail 6228CTH80 Steerable Catheter Set | Medtronic, Inc. | 2008 | — |
| +2 | K070051 | Acumen Insight Endocardial Visualization System | Acumen Medical, Inc. | 2007 | — |
| +3 | 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 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (3)
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.
What descends from it? (5)
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 14 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 42 ancestors have a recall of any class.
- Of its descendants, K042381 (Acumen Medical, Inc., 2004) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K031211.
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 Attain Prevail Left Heart Delivery System is indicated 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/K032622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032622: Attain Prevail Left Heart Delivery System Moddel, 6228SYS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032622
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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