510(k) · Cleared
ClearedMitraClip G4 Steerable Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DRA Catheter, Steerable
Cleared on Sep 28, 2022 as substantially equivalent to K190167 (Abbott, 2019) after a 138-day review. Its family tree reaches back 2 generations to 2017. 2 later devices descend from it.
- Decided
- Sep 28, 2022
- Review
- 138 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K172394 (2017). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK172394 Steerable Guide CatheterAbbott Vascular · 2017
- 1 generation backK190167 MitraClip G4 Steerable Guide CatheterAbbott · 2019
- This deviceK221397 MitraClip G4 Steerable Guide CatheterAbbott Medical · 2022
- Descendant · cites it directly · 1 of its ownK241538 TriClip Steerable Guide CatheterAbbott Medical · 2024
- Descendant · 2 generations on · 0 of its ownK243224 MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5…Abbott Medical · 2024
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 |
|---|---|---|---|---|---|
| −2 | K172394 | Steerable Guide Catheter | Abbott Vascular | 2017 | — |
| −1 | K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | 2019 | — |
| 0 (this device) | K221397 | MitraClip G4 Steerable Guide Catheter | Abbott Medical | 2022 | — |
| +1 | K241538 | TriClip Steerable Guide Catheter | Abbott Medical | 2024 | — |
| +2 | K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide… | Abbott Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 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 |
|---|---|---|---|
| * | K190167 | MitraClip G4 Steerable Guide CatheterSummary page 4…eter, Steerable Regulatory Class: II Product Code: DRA III. PREDICATE DEVICE K190167 Steerable Guide Catheter IV. DEVICE DESCRIPTION The Steerable Guide Catheter (including a dilator) consists of a dis… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241538 | TriClip Steerable Guide Catheter | 2024 | 1 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241538 (Abbott Medical, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through interatrial septum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221397: MitraClip G4 Steerable Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221397
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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