510(k) · Cleared
Recalled · Class II · 2012Stealth 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 Mar 11, 2011 as substantially equivalent to K071350 (Cardiovascular Systems, Inc., 2007) and 1 other predicate after a 29-day review. Its family tree reaches back 7 generations to 1987. 1 of the 36 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it. It has been recalled once.
- Decided
- Mar 11, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K871011 (1987). 15 ancestors in all. 20 later devices descend from it, 9 citing it directly. 1 of the 36 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 6 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 5 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 4 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 3 generations backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 2 generations backK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- 1 generation backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- This deviceK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
- Descendant · cites it directly · 6 of its ownK122987 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK131092 Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascular Systems, Inc. · 2019 · Recalled
- Descendant · cites it directly · 4 of its ownK133399 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · Recalled (Class I)
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…cites it directly · 2013
Most influential descendants
Showing 5 of 20 · See all- K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · cites it directly8descendants
- K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012 · cites it directly6descendants
- K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013 · cites it directly5descendants
- K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc. · 2019 · 2 generations on4descendants
- K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −6 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −5 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −4 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −3 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −2 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| −1 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| 0 (this device) | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | — |
| +1 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015 | 3 |
| +1 | K122987 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2012 | — |
| +1 | K131092 | Stealth 360 Orbital Pad System | Cardio Systems, Inc. | 2013 | — |
| +2 | K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral… | Cardiovascular Systems, Inc. | 2019 | 2 |
| +1 | K133399 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | 2013 | Class I |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K071350 | Diamondback 360 Degree Orbital Atherectomy SystemSummary page 1…cation Name: Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW) Predicate Devices: 5 10(k) Number: K07 1350 Manufacture: Cardiovascular Systems, Inc. Trade Name: Diamon… | 2007 |
| * | K090521 | Diamondback 360 DBXSummary page 1…Cardiovascular Systems, Inc. Trade Name: Diamondback 360® Orbital Atherectomy System 5 10(k) Number: K090521 Manufacture: Cardiovascular Systems, Inc. Trade Name: Diamon… | 2009 |
What descends from it? (20)
See all 209 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | 2015 | 8 |
| K122987 | Stealth 360 Orbital Pad System | 2012 | 6 |
| K131092 | Stealth 360 Orbital Pad System | 2013 | 5 |
| K133399 | Diamondback 360 Peripheral Orbital Atherectomy System Class I | 2013 | 4 |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | 2023 | 3 |
| K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | 2015 | 2 |
| K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System… | 2015 | 1 |
| K133999 | Diamondback 360 Peripheral Orbital Atherectomy System | 2014 | 0 |
| K111388 | Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System | 2011 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2012 | Class II | Z-1959-2012 | Employee error | CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft. |
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 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 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.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K152694 (Cardiovascular Systems, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 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 Stealth 360' Orbital PAD 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/K110389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110389: 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/K110389
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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