510(k) · Cleared
ClearedAttain LDS 6216 Left-Heart 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 Aug 28, 2001 as substantially equivalent to K950490 (Medtronics Interventional Vascular, 1995) and 4 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1989. 5 of the 105 devices in its family, counting itself, have a Class I recall. 97 later devices descend from it.
- Decided
- Aug 28, 2001
- Review
- 50 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K893658 (1989). 7 ancestors in all. 97 later devices descend from it, 6 citing it directly. 5 of the 105 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 1 generation backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- This deviceK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- Descendant · cites it directly · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- Descendant · 2 generations on · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- Descendant · 2 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- Descendant · cites it directly · 31 of its ownK021587 Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular · 2002 · Recalled
- Descendant · 3 generations on · 30 of its ownK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 97 · See all- K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · cites it directly80descendants
- K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · 2 generations on37descendants
- K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 2 generations on35descendants
- K021587Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular · 2002 · cites it directly31descendants
- K072313Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −1 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| 0 (this device) | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| +1 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| +2 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| +2 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| +1 | K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216A | Medtronic Vascular | 2002 | 1 |
| +3 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 12 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 1 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 1 |
| 2022 | 2 | 1 |
| 2023 | 3 | 0 |
| 2024 | 5 | 1 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K950490 | Medtronic GC IV Coronary Guiding CatheterSummary page 2…LDS 6216 Left-heart Delivery System Aftachments Substantially Equivalent Devices Attain LDS 6216 Left-heart Delivery System Predicate Devices Medtronic Interventional K950490 Medtronic GC IV Coronary Guiding Catheter Vascular (MIV) Danvers, MA 01923 SafeSheath MSP (Same as | Thomas Medical K003731 Saf… | 1995 |
| * | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveSummary page 2…Predicate Devices Medtronic Interventional K950490 Medtronic GC IV Coronary Guiding Catheter Vascular (MIV) Danvers, MA 01923 SafeSheath MSP (Same as | Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 GC III (Vector, Vector X) | Medtronic Interventional K950179 Coronary Guiding Catheter | Vascul… | 2001 |
| * | K950179 | Medtronic (R) GC Iii Coronary Guiding CatheterSummary page 2…Vascular (MIV) Danvers, MA 01923 SafeSheath MSP (Same as | Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 GC III (Vector, Vector X) | Medtronic Interventional K950179 Coronary Guiding Catheter | Vascular (MIV) Danvers, MA 01923 Zuma Guiding Catheter Medtronic Interventional K990707 Vascular (MIV… | 1995 |
| * | K990707 | Medtronic 5F & 9F Zuma Guiding CathetersSummary page 2…GC III (Vector, Vector X) | Medtronic Interventional K950179 Coronary Guiding Catheter | Vascular (MIV) Danvers, MA 01923 Zuma Guiding Catheter Medtronic Interventional K990707 Vascular (MIV) Danvers, MA 01923 | Percutaneous Introducer Kit | MedAmicus K965167 (Component) Minneapolis, MN 55447 SafeSheath M… | 1999 |
| * | K965167 | Percutaneous Venous Introducer 10264Summary page 2…eter | Vascular (MIV) Danvers, MA 01923 Zuma Guiding Catheter Medtronic Interventional K990707 Vascular (MIV) Danvers, MA 01923 | Percutaneous Introducer Kit | MedAmicus K965167 (Component) Minneapolis, MN 55447 SafeSheath MSP (Same as | Thomas Medical K003731 SafeSheath CSG) Malvern, PA 19355 Percutaneous… | 1997 |
What descends from it? (97)
See all 976 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013517 | 10600 Deflectable Catheter System, Model 10600 | 2002 | 80 |
| K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216A | 2002 | 31 |
| K053400 | Acumen Single-Lumen Delivery Sheath | 2006 | 11 |
| K020821 | Scout (Sinus Cornarius Utility Tool), Model 335 117 | 2002 | 8 |
| K052459 | 6248VAL Adjustable Valve | 2006 | 0 |
| K023937 | Cook Vascular Serpenta Coronary Sinus Introducer System | 2003 | 0 |
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 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K013517 (Medtronic Vascular, 2002) has gone furthest, with 80 descendants of its own.
- 1 other device also cites its predicate K950490.
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™ LDS 6216 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/K012130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012130: Attain LDS 6216 Left-Heart 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/K012130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026