510(k) · Cleared
ClearedAttain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · DQY Catheter, Percutaneous
Cleared on Nov 7, 2022 as substantially equivalent to K192712 (Medtronic, Inc., 2020) after a 46-day review. Its family tree reaches back 11 generations to 1989.
- Decided
- Nov 7, 2022
- Review
- 46 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K893658 (1989). 59 ancestors in all, the oldest K760385 (1976). No later device cites it as a predicate yet.
- Root · 11 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 7 generations between
- 3 generations backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- 2 generations backK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- 1 generation backK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020
- This deviceK222873 Attain Command + SureValve Delivery System, Attain Select II +…Medtronic · 2022
Show all 11 generations
- Root · 11 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 10 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 9 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 8 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 7 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 6 generations backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- 5 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 4 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 3 generations backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- 2 generations backK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- 1 generation backK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020
- This deviceK222873 Attain Command + SureValve Delivery System, Attain Select II +…Medtronic · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −10 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −9 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −8 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −7 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −6 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| −5 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| −4 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| −3 | 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 |
| −1 | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command +… | Medtronic, Inc. | 2020 | — |
| 0 (this device) | K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve… | Medtronic | 2022 | — |
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 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Summary page 5…Class II Classification Panel: Cardiovascular Predicate Device: Attain CommandTM + SureValveTM Guide catheter for left-heart delivery - (Attain Command + K192712 SureValve) Predicate Device: Attain SelectTM II + SureValveTM delivery catheter system - K192712 (Attain Select II + SureVal… | 2020 |
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 33 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 11 of the 59 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus and into the right ventricle.
The Attain Select II + SureValve delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus, left-heart venous anatomy, and the right ventricle. For left heart use, the delivery catheter system is indicated for use with outer guide catheters. For right ventricle use, the delivery catheter system is indicated for use without an outer guide catheter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222873: Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222873
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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