510(k) · Cleared
ClearedAMPLATZER TorqVue 45x45 Delivery Sheath
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 CO · DQY Catheter, Percutaneous
Cleared on Dec 23, 2016 as substantially equivalent to K120120 (Aga Medical Corporation, 2012) and 1 other predicate after a 56-day review. Its family tree reaches back 9 generations to 1989. 1 of the 46 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Dec 23, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K893658 (1989). 41 ancestors in all, the oldest K770977 (1977). 4 later devices descend from it, 1 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations between
- 3 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 2 generations backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 1 generation backK120120 Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1…Aga Medical Corporation · 2012
- This deviceK163000 AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO · 2016
- Descendant · cites it directly · 3 of its ownK212026 Amplatzer Steerable Delivery SheathAbbott Medical · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK220340 Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK232690 Amulet™ Steerable Delivery SheathAbbott Medical · 2023
- Descendant · 4 generations on · 0 of its ownK250426 Amulet™ Steerable Delivery SheathAbbott 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 backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 1 generation backK120120 Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1…Aga Medical Corporation · 2012
- This deviceK163000 AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO · 2016
Class I recalls in this family
- K220340 Amplatzer Steerable Delivery Sheath2 generations on · 2022
Most influential descendants
Showing 4 of 4 · See all- K212026Amplatzer Steerable Delivery SheathAbbott Medical · 2021 · cites it directly3descendants
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 2 generations on2descendants
- K232690Amulet™ Steerable Delivery SheathAbbott Medical · 2023 · 3 generations on1descendant
- K250426Amulet™ Steerable Delivery SheathAbbott Medical · 2025 · 4 generations on0descendants
View 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 | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… | Aga Medical Corp. | 2009 | — |
| −1 | K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath… | Aga Medical Corporation | 2012 | — |
| 0 (this device) | K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016 | — |
| +1 | K212026 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2021 | 1 |
| +2 | K220340 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2022 | Class I |
| +3 | K232690 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2023 | — |
| +4 | K250426 | Amulet™ Steerable Delivery Sheath | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 1 |
| 2023 | 1 | 0 |
| 2025 | 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.
1 device in this family has 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? (2)
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 |
|---|---|---|---|
| * | K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…Summary page 4…Percutaneous Product Code: DQY Predicate Primary Predicate-AMPLATZER™ TorqVue™ LA and AMPLATZER TorqVue Device(s): 45°x45° (14 Fr) Delivery Sheaths (K120120) Secondary Predicate-AMPLATZER™ TorqVue™ 45°x45° Delivery Sheath 9-13 Fr sizes (K083214)… | 2012 |
| * | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Summary page 4…s): 45°x45° (14 Fr) Delivery Sheaths (K120120) Secondary Predicate-AMPLATZER™ TorqVue™ 45°x45° Delivery Sheath 9-13 Fr sizes (K083214) Page 1 of 3 Special 510… | 2009 |
| † | K072313 | Amplatzer Torqvue Delivery System | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212026 | Amplatzer Steerable Delivery Sheath | 2021 | 3 |
Has anything in its family been recalled? (1 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.
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 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 2.8 years on median.
- 6 of the 41 ancestors have a recall of any class.
- Of its descendants, K212026 (Abbott Medical, 2021) has gone furthest, with 3 descendants of its own.
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™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163000 · printed Nov 3, 2026
Cite this page
510(k) Report. “K163000: AMPLATZER TorqVue 45x45 Delivery Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K163000
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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