510(k) · Cleared
Recalled · Class II · 2021Amplatzer Steerable Delivery Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DQY Catheter, Percutaneous
Cleared on Sep 27, 2021 as substantially equivalent to K163000 (Aga Medical COrporation (Wholly Owned by St. Jude Medical CO, 2016) and 1 other predicate after a 90-day review. Its family tree reaches back 10 generations to 1989. 1 of the 52 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 27, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K893658 (1989). 48 ancestors in all, the oldest K770977 (1977). 3 later devices descend from it, 1 citing it directly. 1 of the 52 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations between
- 3 generations backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 2 generations backK120120 Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1…Aga Medical Corporation · 2012
- 1 generation backK163000 AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO · 2016
- This deviceK212026 Amplatzer Steerable Delivery SheathAbbott Medical · 2021
- Descendant · cites it directly · 2 of its ownK220340 Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK232690 Amulet™ Steerable Delivery SheathAbbott Medical · 2023
- Descendant · 3 generations on · 0 of its ownK250426 Amulet™ Steerable Delivery SheathAbbott Medical · 2025
Show all 10 generations
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 9 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 8 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 7 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 6 generations backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- 5 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- 4 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 3 generations backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 2 generations backK120120 Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1…Aga Medical Corporation · 2012
- 1 generation backK163000 AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO · 2016
- This deviceK212026 Amplatzer Steerable Delivery SheathAbbott Medical · 2021
Class I recalls in this family
- K220340 Amplatzer Steerable Delivery Sheathcites it directly · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −9 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −8 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −7 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −6 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| −5 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| −4 | 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 | — |
| −2 | K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath… | Aga Medical Corporation | 2012 | — |
| −1 | K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016 | — |
| 0 (this device) | K212026 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2021 | — |
| +1 | K220340 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2022 | Class I |
| +2 | K232690 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2023 | — |
| +3 | 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 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K163000 | AMPLATZER TorqVue 45x45 Delivery SheathSummary page 4…Percutaneous (21 CFR 870.1250) Regulatory Class: II Product Code: DQY III. PREDICATE DEVICES Primary Predicate: TorqVue™ 45x45 Delivery Sheath (K163000, cleared December 23, 2016) Reference Predicate: Agilis™ NxT Steerable Introducer (K081645, cleared June 11, 2008) IV. DE… | 2016 |
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 4…PREDICATE DEVICES Primary Predicate: TorqVue™ 45x45 Delivery Sheath (K163000, cleared December 23, 2016) Reference Predicate: Agilis™ NxT Steerable Introducer (K081645, cleared June 11, 2008) IV. DEVICE DESCRIPTION The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220340 | Amplatzer Steerable Delivery Sheath Class I | 2022 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2021 | Class II | Z-0895-2022 | Device Design | Instructions for use were updated. |
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 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- 10 of the 48 ancestors have a recall of any class.
- Of its descendants, K220340 (Abbott Medical, 2022) has gone furthest, with 2 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. 2021, 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 Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer Amulet Left Atrial Appendage Occluder.
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/K212026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212026: Amplatzer Steerable Delivery Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212026
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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