510(k) · Cleared
ClearedAttain Prevail Steerable Catheter Set, Model 6228CTH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Jul 17, 2003 as substantially equivalent to K013517 (Medtronic Vascular, 2002) and 9 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1989. 29 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K893658 (1989). 41 ancestors in all, the oldest K760385 (1976). 29 later devices descend from it, 4 citing it directly.
- 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 deviceK031211 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 · 2 generations on · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- Descendant · 3 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- Descendant · 4 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
- Descendant · 5 generations on · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · cites it directly17descendants
- K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · 2 generations on14descendants
- K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 3 generations on13descendants
- K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 4 generations on12descendants
- K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · 5 generations on8descendants
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) | 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 | — |
| +2 | 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 | — |
| +4 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
| +5 | K101885 | Medtronic C315 Delivery Catheter | Medtronic, Inc. | 2010 | 1 |
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 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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? (12)
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 |
| * | K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216A | 2002 |
| * | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218 | 2002 |
| * | K931794 | Marinr Series EP Diagnostic CathetersSummary page 2…System ~_ Medtronic Marinr Medtronic K93 1794 Series EP Diagnostic Catheters… | 1994 |
| * | K974683 | Naviport Deflectable Tip Guiding CatheterSummary page 2…Catheters ~- Cardima Naviport Cardima Inc. K974683 Deflectable Guiding Catheter Stainless Steel Medtronic AVE… | 1999 |
| * | P790017 | Usci Dilatation CatheterSummary page 2…Steel Medtronic AVE Medtronic AVE Approved 10/7/86 Guidewire St eerab I e G u i dew i res with P790017/S8 prior to down-… | 1980 |
| * | K945461 | Piton (TM) Y-Pack and Piton (TM) Tri-Pack)Summary page 2…guide wires. - Y Connector with Interventional Vascular Medtronic AVE K945461 Adjustable Y-Adapter Hemostasis Valve ~-… | 1995 |
| * | K895580 | Y-Adapter W/Thouy Borst | 1990 |
| * | K760385 | Extension SetsSummary page 2…Valve ~_ Extension Tubing Smallbore Extension B Braun K760385 Set Stopcock Medex Stopcock and Medex, Inc. Pre-amendment… | 1976 |
| * | K921702 | Meri-Dapt (TM) Hemostasis Valve/Torqloc Torque Devi | 1992 |
| * | — | Medex Stopcock and Luer Lock Plug Model MX531-1L Named without a submission number | |
| * | — | Guide Wire Clip Named without a submission number |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | 2004 | 17 |
| K032622 | Attain Prevail Left Heart Delivery System Moddel, 6228SYS | 2003 | 5 |
| K052575 | Luminary Cannulator Bideflectable Catheter with Lumen | 2006 | 4 |
| K082670 | Modification to: Attain Prevail 6228CTH80 Steerable Catheter Set | 2008 | 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 14 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K042194 (Medtronic Vascular, 2004) has gone furthest, with 17 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 Attain Prevail Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031211: Attain Prevail Steerable Catheter Set, Model 6228CTH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031211
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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