510(k) · Cleared
ClearedAttain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 9, 2008 as substantially equivalent to K053431 (Medtronic, Ireland, 2006) and 4 other predicates after a 294-day review. Its family tree reaches back 7 generations to 1989. 13 later devices descend from it.
- Decided
- Dec 9, 2008
- Review
- 294 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K893658 (1989). 51 ancestors in all, the oldest K760385 (1976). 13 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 5 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 4 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 3 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 2 generations backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- 1 generation backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- This deviceK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- Descendant · cites it directly · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
- Descendant · 4 generations on · 3 of its ownK230363 CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023
- Descendant · cites it directly · 3 of its ownK123153 Attain Command+Surevalve Left Heart Delivery System Attain Command…Medtronic, Ireland · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · cites it directly12descendants
- K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · 2 generations on8descendants
- K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · 3 generations on5descendants
- K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023 · 4 generations on3descendants
- K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −6 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −5 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −4 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −3 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −2 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| −1 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| 0 (this device) | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| +1 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| +2 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 1 |
| +3 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3… | Centerpoint Systems | 2019 | — |
| +4 | K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | 2023 | — |
| +1 | K123153 | Attain Command+Surevalve Left Heart Delivery System Attain Command Guide… | Medtronic, Ireland | 2013 | — |
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 | 5 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053431 | Attain Select II 6248DEL Delivery Catheter SystemSummary page 2…of operation to the following predicate devices: • Attain SelectTM II 6248DEL Delivery Catheter System (510(k) K05343 1). * AttainTM Access 6218A Left Heart Delivery System (510(k) K021589). Also… | 2006 |
| * | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218Summary page 2…• Attain SelectTM II 6248DEL Delivery Catheter System (510(k) K05343 1). * AttainTM Access 6218A Left Heart Delivery System (510(k) K021589). Also commercialized under this 510(k) number is the AttainTM 6218A-45S, 6218A-… | 2002 |
| * | K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216ASummary page 2…atheters for Left-Heart Delivery individual packs. * AttainTM LDS 6216A Left Heart Delivery System (510(k) K021587). Also M… | 2002 |
| * | K024035 | Attain 6218A-AM Amplatz Guide Catheter for Left-Heart DeliverySummary page 2…Catheter for Left-Heart Delivery. • AttainTM 6218A-AM Guide Catheter for Left-Heart Delivery (510(k) K024035). Also commercialized under this 510(k) number is the AttainTM 6218A-EH Guide Catheter for Left-H… | 2002 |
| * | K024032 | Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart DeliverySummary page 2…6218A-EH Guide Catheter for Left-Heart Delivery individual pack. • AttainTM 6218A-MP Guide Catheter for Left-Heart Delivery (510(k) K024032) Medtronic Ireland Attain CommandT Left Heart Delivery Systems and Attain Command Guide Catheters for Left Heart Del Tr… | 2002 |
What descends from it? (13)
See all 132 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 19 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 51 ancestors have a recall of any class.
- Of its descendants, K090659 (Medtronic, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K053431.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Medtronic Attain Command 6250 Left Heart Delivery Systems and the Medtronic Attain Command 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080428: Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080428
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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