510(k) · Cleared
ClearedAttain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 3, 2020 as substantially equivalent to K101885 (Medtronic, Inc., 2010) and 1 other predicate after a 311-day review. Its family tree reaches back 10 generations to 1989. 1 later device descends from it.
- Decided
- Aug 3, 2020
- Review
- 311 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K893658 (1989). 58 ancestors in all, the oldest K760385 (1976). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations between
- 3 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 2 generations backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- 1 generation backK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- This deviceK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK222873 Attain Command + SureValve Delivery System, Attain Select II +…Medtronic · 2022
Show all 10 generations
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 9 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 8 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 7 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 6 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 5 generations backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- 4 generations backK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- 3 generations backK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- 2 generations backK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- 1 generation backK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
- This deviceK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −9 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −8 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −7 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −6 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −5 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| −4 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| −3 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| −2 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| −1 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 1 |
| 0 (this device) | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command +… | Medtronic, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K101885 | Medtronic C315 Delivery CatheterSummary page 9…ice uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices: • C315 Delivery Catheter (K101885, cleared on September 9, 2010) • Attain Select™ II + SureValve™ delivery catheter system (K123153, cleared on April 9… | 2010 |
| * | K123153 | Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Summary page 9…to the following predicate devices: • C315 Delivery Catheter (K101885, cleared on September 9, 2010) • Attain Select™ II + SureValve™ delivery catheter system (K123153, cleared on April 9, 2013) • Attain Command™ + SureValve™ Product families (Left Heart Delivery System and Gui… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | 2022 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 11 of the 58 ancestors have a recall of any class.
- Of its descendants, K222873 (Medtronic, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K101885.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters.
The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
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/K192712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192712: Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192712
Report an extraction error
Are you the manufacturer?
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