510(k) · Cleared
ClearedModification to Diamondback 360 Degree Orbital Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Systems, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Aug 14, 2008 as substantially equivalent to K072748 (Cardiovascular Systems, Inc., 2007) and 1 other predicate after a 37-day review. Its family tree reaches back 5 generations to 1987. 1 of the 39 devices in its family, counting itself, has a Class I recall. 25 later devices descend from it.
- Decided
- Aug 14, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871011 (1987). 13 ancestors in all. 25 later devices descend from it, 1 citing it directly. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 4 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 3 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 2 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 1 generation backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- This deviceK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 20 of its ownK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 8 of its ownK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 6 of its ownK122987 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012
- Descendant · 3 generations on · 5 of its ownK131092 Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…3 generations on · 2013
Most influential descendants
Showing 5 of 25 · See all- K090521Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · cites it directly24descendants
- K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · 2 generations on20descendants
- K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · 3 generations on8descendants
- K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012 · 3 generations on6descendants
- K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −4 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −3 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −2 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −1 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| 0 (this device) | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| +1 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| +2 | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | 1 |
| +3 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015 | 3 |
| +3 | K122987 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2012 | — |
| +3 | K131092 | Stealth 360 Orbital Pad System | Cardio Systems, Inc. | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K072748 | Modification to: Diamondback 360 Orbital Atherectomy SystemSummary page 1…ation Name: Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW) Predicate Device: 510(k) Number: K072748 Manufacture: Cardiovascular Systems, Inc. Trade Name: Di… | 2007 |
| * | K071350 | Diamondback 360 Degree Orbital Atherectomy SystemSummary page 1…iovascular Systems, Inc. Trade Name: Diamondback 3600TM Orbital Atherectomy System 5 10(k) Number: K071350 Manufacture: Cardiovascular Systems, Inc. Trade Name: Di… | 2007 |
| † | K071427 | Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | 2007 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090521 | Diamondback 360 DBX | 2009 | 24 |
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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K090521 (Cardiovascular Systems, Inc., 2009) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K072748.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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° TM 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 Diamondback 3600TM Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081944: Modification to Diamondback 360 Degree 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/K081944
Report an extraction error
Are you the manufacturer?
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