510(k) · Cleared
ClearedAttain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery System, Attain 6216A and 6218A Guid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 27, 2011 as substantially equivalent to K021589 (Medtronic Vascular, 2002) and 4 other predicates after a 24-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Oct 27, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K893658 (1989). 53 ancestors in all, the oldest K760385 (1976). No later device cites it as a predicate yet.
- 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 deviceK112917 Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A…Medtronic, Inc. · 2011
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 deviceK112917 Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A…Medtronic, Inc. · 2011
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) | K112917 | Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart… | Medtronic, Inc. | 2011 | — |
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 |
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 |
|---|---|---|---|
| * | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218Summary page 3…dicate devices: * Attain Access 6218BA Left Heart DeliverySse 50k K02 1589). Also commercialized under this 5 10(k) number is the Attain 6218A-45S, 621… | 2002 |
| * | K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216ASummary page 3…al packs. * Attain LDS 621 6A Left Heart Delivery System (5 10(k) K02 1587). Also commercialized under this 5 10(k) number is the AttainTM 621 6A-M82 G… | 2002 |
| * | K024035 | Attain 6218A-AM Amplatz Guide Catheter for Left-Heart DeliverySummary page 3…* Attain 621 BA-AM Guide Catheter for Left-Heart Delivery (5 10(k) K024035). Also commercialized under this 5 10(k) number is the Attainrm 621 8A-EH… | 2002 |
| * | K024032 | Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart DeliverySummary page 3…* Attain 621 6A-MP Guide Catheter for Left-Headt Delivery (5 10(k) K02403 2) " Attain Command 6250 Left Heart Delivery Systems and… | 2002 |
| * | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Summary page 3…" Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery (5 10(k) K090659). Medirorwe Ireland Attain 6216AN6218A Product Family Special 510(k)… | 2009 |
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 22 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.
- 7 other devices also cite its predicate K021589.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 6216A/6218A Product Family is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112917: Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery System, Attain 6216A and 6218A Guid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112917
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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