510(k) · Cleared
Recalled · 2008Attain Access 6218A Left-Heart Delivery System, Model 6218
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on May 30, 2002 as substantially equivalent to K012083 (Medtronic Vascular, 2001) after a 15-day review. Its family tree reaches back 3 generations to 1977. 31 later devices descend from it. It has been recalled once.
- Decided
- May 30, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K770977 (1977). 30 ancestors in all. 31 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
- 2 generations backK963320 TFX Medical GuidewireTfx Medical Group · 1996
- 1 generation backK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
- This deviceK021589 Attain Access 6218A Left-Heart Delivery System, Model 6218Medtronic Vascular · 2002
- Descendant · cites it directly · 29 of its ownK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- Descendant · cites it directly · 17 of its ownK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- Descendant · cites it directly · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- Descendant · cites it directly · 14 of its ownK024032 Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart DeliveryMedtronic Vascular · 2002
- Descendant · cites it directly · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003 · cites it directly29descendants
- K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · cites it directly17descendants
- K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · cites it directly14descendants
- K024032Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart DeliveryMedtronic Vascular · 2002 · cites it directly14descendants
- K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| −2 | K963320 | TFX Medical Guidewire | Tfx Medical Group | 1996 | — |
| −1 | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2001 | — |
| 0 (this device) | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2002 | — |
| +1 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| +1 | 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 | — |
| +1 | K024032 | Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart Delivery | Medtronic Vascular | 2002 | — |
| +1 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218Summary page 2…Access Predicate Device Predicate Device Manufacturer | Predicate 510(k) 6218A Left-heart Delivery System Device 45cmand 50 cm | Medtronic Attain Access Medtronic, Inc. K012083 Guide Catheters 6218 Left-heart Delivery Minneapolis, MN 55432 System Guide Catheter Medtronic Attain Access Medtronic, Inc. K012… | 2001 |
What descends from it? (31)
See all 318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | 2003 | 29 |
| K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | 2004 | 17 |
| K053431 | Attain Select II 6248DEL Delivery Catheter System | 2006 | 14 |
| K024032 | Attain 6216A-MP Multi-Purpose Guide Catheter for Left-Heart Delivery | 2002 | 14 |
| K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters… | 2008 | 13 |
| K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | 2003 | 5 |
| K112917 | Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery… | 2011 | 0 |
| K053277 | CPS Direct SL Outer Catheter | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 27, 2008 | Not classified | Z-2473-2008 | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K031211 (Medtronic Vascular, 2003) has gone furthest, with 29 descendants of its own.
- 6 other devices also cite its predicate K012083.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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™ Access 6218A Left-heart delivery system 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021589
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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