PMA · Approved
Recalled · Class I · 2018Diamondback 360 Coronary Orbital Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Systems, Inc. · MCX Catheter, Coronary, Atherectomy
Approved on Oct 21, 2013 through premarket approval, which rests on the device’s own clinical evidence after a 220-day review. It has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Oct 21, 2013
- Review
- 220 days
- Class
- Class III
- Product code
- MCX
- Recalls
- 2 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P130005 has 49 supplements since 2014: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2014 | 2 |
| 2015 | 7 |
| 2016 | 4 |
| 2017 | 6 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 6 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 4 |
Sources: FDA PMA database (decision fields and supplements), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2018 | Class II | Z-3021-2018 | Device Design | The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. |
| Mar 4, 2015 | Class I | Z-1290-2015 | Nonconforming Material/Component | The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MCX devicesMCX Catheter, Coronary, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MCX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCX
Too few MCX 510(k)s in any year since 2007 to give a median.
Recalls per year · MCX
2in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MCX
864in 2025
MAUDE reports naming product code MCX, 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 | 8 | — | 2 | 107 |
| 2008 | 8 | — | 0 | 185 |
| 2009 | 10 | — | 0 | 289 |
| 2010 | 5 | — | 0 | 319 |
| 2011 | 12 | — | 0 | 333 |
| 2012 | 10 | — | 0 | 293 |
| 2013 | 13 | — | 0 | 355 |
| 2014 | 18 | — | 0 | 412 |
| 2015 | 25 | — | 2 (2) | 629 |
| 2016 | 16 | — | 0 | 713 |
| 2017 | 23 | — | 0 | 735 |
| 2018 | 13 | — | 0 | 876 |
| 2019 | 15 | — | 1 | 788 |
| 2020 | 20 | — | 0 | 822 |
| 2021 | 9 | — | 1 | 901 |
| 2022 | 12 | — | 2 | 720 |
| 2023 | 18 | — | 0 | 706 |
| 2024 | 9 | — | 0 | 798 |
| 2025 | 10 | — | 0 | 864 |
| 2026 | 10 | — | 0 | — |
https://510kreport.com/device/P130005 · printed Nov 6, 2026
Cite this page
510(k) Report. “P130005: Diamondback 360 Coronary Orbital Atherectomy System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P130005
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026