510(k) · Cleared
ClearedMitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DQY Catheter, Percutaneous
Cleared on Dec 31, 2024 as substantially equivalent to K241538 (Abbott Medical, 2024) after an 85-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Dec 31, 2024
- Review
- 85 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K893658 (1989). 45 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet.
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations between
- 3 generations backK080757 Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008
- 2 generations backK131063 Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · Recalled
- 1 generation backK241538 TriClip Steerable Guide CatheterAbbott Medical · 2024
- This deviceK243224 MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5…Abbott Medical · 2024
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 backK080757 Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008
- 2 generations backK131063 Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · Recalled
- 1 generation backK241538 TriClip Steerable Guide CatheterAbbott Medical · 2024
- This deviceK243224 MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5…Abbott Medical · 2024
View 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 | K080757 | Amplatzer Torqvue Low Profile Delivery System | Aga Medical Corp. | 2008 | — |
| −2 | K131063 | Amplatzer Torq Vue LP Delivery System | St Jude Medical | 2013 | 1 |
| −1 | K241538 | TriClip Steerable Guide Catheter | Abbott Medical | 2024 | — |
| 0 (this device) | K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide… | Abbott Medical | 2024 | — |
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 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K241538 | TriClip Steerable Guide CatheterSummary page 6…Regulatory Class: II Product Code: DQY III. PREDICATE DEVICES TriClip Steerable Guide Catheter (K241538) IV. REFERENCE DEVICE MitraClip G4 Steerable Guide Catheter (K221397) IV. DEVICE DESCRIPTION T… | 2024 |
| † | K221397 | MitraClip G4 Steerable Guide Catheter | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 7 of the 45 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 MitraClip G5 Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The TriClip G5 Steerable Guide Catheter is used for introducing various cardiovascular catheters into the right side of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243224: MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243224
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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