510(k) · Cleared
ClearedAttain 6226DEF Deflectable Catheter Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Oct 21, 2003 as substantially equivalent to K013517 (Medtronic Vascular, 2002) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1989. 5 of the 74 devices in its family, counting itself, have a Class I recall. 37 later devices descend from it.
- Decided
- Oct 21, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K893658 (1989). 36 ancestors in all, the oldest K770977 (1977). 37 later devices descend from it, 3 citing it directly. 5 of the 74 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 3 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 2 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 1 generation backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- This deviceK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- Descendant · cites it directly · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- Descendant · 2 generations on · 30 of its ownK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- Descendant · 3 generations on · 10 of its ownK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- Descendant · 3 generations on · 7 of its ownK080757 Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008
- Descendant · 3 generations on · 5 of its ownK131063 Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 37 · See all- K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · cites it directly35descendants
- K072313Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · 2 generations on30descendants
- K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Aga Medical Corp. · 2009 · 3 generations on10descendants
- K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008 · 3 generations on7descendants
- K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −3 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −2 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −1 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| 0 (this device) | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| +1 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| +2 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
| +3 | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… | Aga Medical Corp. | 2009 | — |
| +3 | K080757 | Amplatzer Torqvue Low Profile Delivery System | Aga Medical Corp. | 2008 | — |
| +3 | K131063 | Amplatzer Torq Vue LP Delivery System | St Jude Medical | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 1 |
| 2022 | 1 | 1 |
| 2023 | 2 | 0 |
| 2024 | 3 | 1 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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.
5 devices in this family have a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013517 | 10600 Deflectable Catheter System, Model 10600 | 2002 |
| * | K010128 | Cook Vascular Peel-Away Hemostasis ValveSummary page 5…517 Deflectable catheter system Minneapolis, MN 55432 Introducer valve Cook 6228VAL Introducer Cook Vascular Incorporated ~010128 Valve Leechburg, PA 15656 USA Universal Slitter Medtronic 6228SLT… | 2002 |
| * | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | 2001 |
| * | — | Medtronic 6228SLT Universal Slitter Named without a submission number |
What descends from it? (37)
See all 373 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K033989 (Medtronic Inc. Cardiac Rhythm Management, 2004) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K013517.
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 deflectable catheter delivery system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and 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/K032312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032312: Attain 6226DEF Deflectable Catheter 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/K032312
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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