510(k) · Cleared
ClearedAcQGuide® VUE Steerable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acutus Medical, Inc. · DRA Catheter, Steerable
Cleared on May 5, 2022 as substantially equivalent to K211100 (Acutus Medical, Inc., 2021) after a 27-day review. Its family tree reaches back 6 generations to 2007.
- Decided
- May 5, 2022
- Review
- 27 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K070357 (2007). No later device cites it as a predicate yet.
- Root · 6 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 5 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 4 generations backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- 3 generations backK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- 2 generations backK162925 AcQGuide Steerable SheathAcutus Medical, Inc. · 2017
- 1 generation backK211100 AcQGuide MAX Steerable SheathAcutus Medical, Inc. · 2021
- This deviceK221044 AcQGuide® VUE Steerable SheathAcutus Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −5 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −4 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| −3 | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| −2 | K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017 | — |
| −1 | K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021 | — |
| 0 (this device) | K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K211100 | AcQGuide MAX Steerable SheathSummary page 4…ubstantial equivalence of the AcQGuide® VUE Steerable Sheath, Model 900201 is the Acutus Medical, Inc. AcQGuide® MAX Steerable Sheath, Model 900200, cleared under 510(k) K211100. This 510(k) is also citing the CARTO VIZIGO Bi-Directional Guiding Sheath cleared under K170997 as a reference device to support… | 2021 |
| † | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | 2017 |
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 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the
vasculature and into the chambers of the heart.
The AcQGuide® VUE deflection facilitates catheter positioning.
The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the
AcQMap System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221044: AcQGuide® VUE Steerable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221044
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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