510(k) · Cleared
ClearedAttain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Ireland · DQY Catheter, Percutaneous
Cleared on Apr 9, 2013 as substantially equivalent to K080428 (Medtronic, Inc., 2008) and 2 other predicates after a 182-day review. Its family tree reaches back 9 generations to 1989. 3 later devices descend from it.
- Decided
- Apr 9, 2013
- Review
- 182 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K893658 (1989). 53 ancestors in all, the oldest K760385 (1976). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations between
- 3 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 2 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 1 generation backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- This deviceK123153 Attain Command+Surevalve Left Heart Delivery System Attain Command…Medtronic, Ireland · 2013
- Descendant · cites it directly · 1 of its ownK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK222873 Attain Command + SureValve Delivery System, Attain Select II +…Medtronic · 2022
- Descendant · cites it directly · 0 of its ownK171819 Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica · 2018
Show all 9 generations
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 8 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 7 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 6 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 5 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 4 generations backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- 3 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 2 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 1 generation backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- This deviceK123153 Attain Command+Surevalve Left Heart Delivery System Attain Command…Medtronic, Ireland · 2013
Most influential descendants
Showing 3 of 3 · See all- K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc. · 2020 · cites it directly1descendant
- K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic · 2022 · 2 generations on0descendants
- K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −8 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −7 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −6 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −5 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −4 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| −3 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K123153 | Attain Command+Surevalve Left Heart Delivery System Attain Command Guide… | Medtronic, Ireland | 2013 | — |
| +1 | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command +… | Medtronic, Inc. | 2020 | — |
| +2 | K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve… | Medtronic | 2022 | — |
| +1 | K171819 | Attain Assist CS Access Catheter | Creganna Medical Also Doing Business AS Ceganna Tactx Medica | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Summary page 2…technology: a Attain Command" 4 6250 Left Heart Delivery Systems (K080428, K090659) * Attain Command T m 6250 Guide Catheters for Left… | 2008 |
| * | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Summary page 2…technology: a Attain Command" 4 6250 Left Heart Delivery Systems (K080428, K090659) * Attain Command T m 6250 Guide Catheters for Left… | 2009 |
| Kept off the family tree | K050428 | FDA’s K050428 is Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars) Our reading of the summary gave K050428, FDA’s number for Technology-Assisted Micro-Mobilization and Reflex… (Advanced Spinal Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Attain Command 6250 Guide Catheters for Left Heart”. Kept off the family tree. Summary page 2…(K080428, K090659) * Attain Command T m 6250 Guide Catheters for Left Heart (K050428, K090659) The Attain Select TM li + SureValve Delivery Catheter System… | 2005 |
| * | K053431 | Attain Select II 6248DEL Delivery Catheter SystemSummary page 2…d technology: *Medtronic Attain Select"' 116248DEL Delivery Catheter System (K053431) Device Description: The Attain Command TM + SureValve h Left Heart Delivery System and Attain Command TM + SureValvem Guide Ca… | 2006 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 53 ancestors have a recall of any class.
- Of its descendants, K192712 (Medtronic, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K080428.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Attain CommandTM + SureValveTM Left Heart Delivery System and Attain CommandTM + SureValveTM 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/K123153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123153: Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for Left Heart Delivery,Attain Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123153
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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