510(k) · Cleared
Recalled · Class II · 2017Diamondback 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 Oct 21, 2015 as substantially equivalent to K110389 (Cardiovascular Systems, Inc., 2011) after a 30-day review. Its family tree reaches back 8 generations to 1987. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 21, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 8 generations to K871011 (1987). 16 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- 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 deviceK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascular Systems, Inc. · 2019 · Recalled
- Descendant · cites it directly · 3 of its ownK182397 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable…Cardiovascular Systems, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK…Cardiovascular Systems, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK170792 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK220568 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascualr Systems, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc. · 2019 · cites it directly4descendants
- K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc. · 2018 · cites it directly3descendants
- K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc. · 2020 · 2 generations on1descendant
- K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2017 · cites it directly1descendant
- K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc. · 2022 · 3 generations on0descendants
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) | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015 | — |
| +1 | K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral… | Cardiovascular Systems, Inc. | 2019 | 2 |
| +1 | K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascular Systems, Inc. | 2018 | — |
| +2 | K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360… | Cardiovascular Systems, Inc. | 2020 | — |
| +1 | K170792 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2017 | — |
| +3 | K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral… | Cardiovascualr Systems, Inc. | 2022 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (1)
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 SystemSummary page 5…ation Regulation: 21 CFR 870.4875—Intraluminal Artery Stripper Classification: II Primary Predicate Device: 510(k) Number: K110389 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Stealth 360°… | 2011 |
| † | K122987 | Stealth 360 Orbital Pad System | 2012 |
| † | K131092 | Stealth 360 Orbital Pad System | 2013 |
| † | K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System… | 2015 |
| † | K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | 2015 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2017 | Class II | Z-0505-2018 | Labeling mix-ups | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. |
| Sep 14, 2017 | Class II | Z-0506-2018 | Labeling mix-ups | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. |
| Dec 7, 2016 | Class II | Z-1230-2017 | Employee error | CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K190634 (Cardiovascular Systems, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 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. 2015, 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/K152694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152694: Diamondback 360 Peripheral Orbital Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152694
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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