510(k) · Cleared
ClearedDiamondback 360 Peripheral Orbital Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Systems, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Feb 28, 2014 as substantially equivalent to K110389 (Cardiovascular Systems, Inc., 2011) and 3 other predicates after a 63-day review. Its family tree reaches back 11 generations to 1987. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 28, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K871011 (1987). 19 ancestors in all. No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 7 generations between
- 3 generations backK122987 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012
- 2 generations backK131092 Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013
- 1 generation backK133399 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · Recalled (Class I)
- This deviceK133999 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2014
Show all 11 generations
- Root · 11 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 10 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 9 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 8 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 7 generations backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 6 generations backK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- 5 generations backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- 4 generations backK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- 3 generations backK122987 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012
- 2 generations backK131092 Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013
- 1 generation backK133399 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · Recalled (Class I)
- This deviceK133999 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2014
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…direct predicate · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −10 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −9 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −8 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −7 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −6 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| −5 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| −4 | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | 1 |
| −3 | K122987 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2012 | — |
| −2 | K131092 | Stealth 360 Orbital Pad System | Cardio Systems, Inc. | 2013 | — |
| −1 | K133399 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | 2013 | Class I |
| 0 (this device) | K133999 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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.
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.
Top candidate predicates for a new MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K110389 | Stealth 360 Orbital Pad System | 2011 |
| * | K122987 | Stealth 360 Orbital Pad SystemSummary page 1…ation: 21 CFR 870.4875-Intraluminal Artery Stripper Classification: 11 Predicate Devices: 510(k) Numbers: KI 10389, K122987, & K(131092 Manufacturer: Cardiovascular Systems, Inc. Trade Name:… | 2012 |
| * | K131092 | Stealth 360 Orbital Pad SystemSummary page 2…bsorbed by the body. This is the same technology that was cleared to market for use in the peripheral arteries for Stealth 3600 in 5 10(k) Ki 10389, K122987, K131092 and for Diamondback 3600 Peripheral per K133399. 6.5 Performance Data The Diamondback 360 Peripheral Orbital Ather… | 2013 |
| * | K133399 | Diamondback 360 Peripheral Orbital Atherectomy SystemSummary page 1…me: Stealth 360'09 Orbital PAD System, Model PRD- SC30-125 5 10(k) Number: K133399 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Diam… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 5 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- 8 other devices also cite its predicate K110389.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133999: Diamondback 360 Peripheral Orbital Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133999
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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