510(k) · Cleared
ClearedDiamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad 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 Jul 26, 2011 as substantially equivalent to K071350 (Cardiovascular Systems, Inc., 2007) and 4 other predicates after a 70-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Jul 26, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K871011 (1987). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 7 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 6 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 5 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 4 generations backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 3 generations backK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- 2 generations backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- 1 generation backK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- This deviceK111388 Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital…Cardiovascular Systems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −7 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −6 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −5 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −4 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −3 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| −2 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| −1 | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | 1 |
| 0 (this device) | K111388 | Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | — |
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 |
| 2008 | 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 MCW? 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? (5)
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 |
|---|---|---|---|
| * | K071350 | Diamondback 360 Degree Orbital Atherectomy SystemSummary page 1…tion Name: Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW) Predicate Devices: 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 StenosisSummary page 1…rdiovascular Systems, Inc. Trade Name: Diamondback 360® Orbital Atherectomy System 5 10(k) Number: K07 1427 Manufacture: Cardiovascular Systems, Inc. Trade Name: Di… | 2007 |
| * | K082981 | Diamondback 360 Degree Orbital Atherectomy System with Viperslide LubricantSummary page 1…rdiovascular Systems, Inc. Trade Name: Diamondback 360® Orbital Atherectomy System 5 10(k) Number: K082981 Manufacture: Cardiovascular Systems, Inc. Trade Name: Di… | 2008 |
| * | K090521 | Diamondback 360 DBXSummary page 1…Diamondback 360® Orbital Atherectomy System with ViperSlide Lubricant 5 10(k) Number: K09052 1 Manufacture: Cardiovascular Systems, Inc. Trade Name: Di… | 2009 |
| * | K110389 | Stealth 360 Orbital Pad SystemSummary page 1…Trade Name: Diamondback Predator 360® Orbital Atherectomy System 5 10(k) Number: K1 10389 Manufacture: Cardiovascular Systems, Inc. Trade Name: St… | 2011 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 17 ancestors have a recall of any class.
- 5 other devices also cite its predicate K071350.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 3600 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 GAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The GAS is a percutaneous orbital atherectomry system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous translumninal angioplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111388: Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111388
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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