510(k) · Cleared
Recalled · Class II · 2021MIVI Mi-AXUS Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mivi Neuroscience, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 9, 2015 as substantially equivalent to K140557 (Mivi, LLC, 2014) and 1 other predicate after a 197-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 9, 2015
- Review
- 197 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010954 (2001). 13 ancestors in all, the oldest K010853 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 4 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 3 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 2 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 1 generation backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- This deviceK151396 MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK201076 Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −5 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −4 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −3 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −2 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −1 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| 0 (this device) | K151396 | MIVI Mi-AXUS Guide Catheter | Mivi Neuroscience, Inc. | 2015 | — |
| +1 | K201076 | Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K140557 | Mivi 6F Guide CatheterSummary page 4…r Devices (DCD) Peripheral Interventional Devices Branch (PIDB) Predicate Device(s) MIVI MI-AXUS 6F Guide Catheter – K140557 Penumbra Neuron™ MAX System – K111380 Device Description The MIVI Mi-Axus 8F Guide Catheter… | 2014 |
| * | K111380 | Neuron Max SystemSummary page 4…nal Devices Branch (PIDB) Predicate Device(s) MIVI MI-AXUS 6F Guide Catheter – K140557 Penumbra Neuron™ MAX System – K111380 Device Description The MIVI Mi-Axus 8F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed fo… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201076 | Anchor Dual Lumen Guidewire Catheter | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2021 | Class II | Z-2442-2021 | Packaging | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
| Jul 23, 2021 | Class II | Z-2441-2021 | Packaging | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K201076 (Aqure Medical, Inc., 2020) has gone furthest, with 0 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. 2015, 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 MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into
a selected blood vessel in the peripheral, coronary and neuro vascular systems.
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/K151396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151396: MIVI Mi-AXUS Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151396
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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