510(k) · Cleared
Recalled · Class II · 2025TorqVue Low Profile Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor · DQY Catheter, Percutaneous
Cleared on Sep 9, 2016 as substantially equivalent to K131063 (St Jude Medical, 2013) after a 32-day review. Its family tree reaches back 9 generations to 1989. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 9, 2016
- Review
- 32 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K893658 (1989). 41 ancestors in all, the oldest K770977 (1977). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations between
- 3 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 2 generations backK080757 Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008
- 1 generation backK131063 Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · Recalled
- This deviceK162228 TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor · 2016
- Descendant · cites it directly · 0 of its ownK261825 Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott · 2026
- Descendant · cites it directly · 0 of its ownK252417 Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical · 2025
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 backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- 4 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- 3 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 2 generations backK080757 Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008
- 1 generation backK131063 Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · Recalled
- This deviceK162228 TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor · 2016
Most influential descendants
Showing 2 of 2 · See allView 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 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| −4 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| −3 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
| −2 | K080757 | Amplatzer Torqvue Low Profile Delivery System | Aga Medical Corp. | 2008 | — |
| −1 | K131063 | Amplatzer Torq Vue LP Delivery System | St Jude Medical | 2013 | 1 |
| 0 (this device) | K162228 | TorqVue Low Profile Delivery Catheter | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | 2016 | — |
| +1 | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026 | — |
| +1 | K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | Abbott Medical | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K131063 | Amplatzer Torq Vue LP Delivery SystemSummary page 4…Catheter, Percutaneous 510(k) K162228 Number: Product Code: DQY Predicate AMPLATZER TorqVue Low Profile Delivery System (K131063) Device(s): Special 510(k) ® AMPLATZER TorqVue Low Profile Delivery Catheter Device The… | 2013 |
| † | K113658 | Amplatzer Vascular Plug 4 | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2025 | Class II | Z-1644-2025 | Process control | Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K261825 (Abbott, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K131063.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 AMPLATZER™ TorqVue™ LP Catheter is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162228: TorqVue Low Profile Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162228
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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