510(k) · Cleared
Recalled · Class II · 2021Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 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 Jul 2, 2019 as substantially equivalent to K152694 (Cardiovascular Systems, Inc., 2015) after a 112-day review. Its family tree reaches back 9 generations to 1987. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 2, 2019
- Review
- 112 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K871011 (1987). 17 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 5 generations between
- 3 generations backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- 2 generations backK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- 1 generation backK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
- This deviceK190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascular Systems, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK…Cardiovascular Systems, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK220568 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascualr Systems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK220109 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK…Cardiovascular Systems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK210586 Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback…Cardiovascular Systems, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 8 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 7 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 6 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 5 generations backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 4 generations backK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- 3 generations backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- 2 generations backK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- 1 generation backK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
- This deviceK190634 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascular Systems, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc. · 2020 · cites it directly1descendant
- K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc. · 2022 · 2 generations on0descendants
- K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc. · 2022 · cites it directly0descendants
- K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −8 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −7 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −6 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −5 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −4 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| −3 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| −2 | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | 1 |
| −1 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015 | 3 |
| 0 (this device) | K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral… | Cardiovascular Systems, Inc. | 2019 | — |
| +1 | K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360… | Cardiovascular Systems, Inc. | 2020 | — |
| +2 | K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral… | Cardiovascualr Systems, Inc. | 2022 | — |
| +1 | K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360… | Cardiovascular Systems, Inc. | 2022 | — |
| +1 | K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth… | Cardiovascular Systems, Inc. | 2021 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K152694 | Diamondback 360 Peripheral Orbital Atherectomy SystemSummary page 4…Atherectomy System Common Name: Intraluminal Artery Stripper Classification: Class II, 21 CFR 870.4875 Product Code: MCW Predicate Device: K152694 - Diamondback 360® Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc.) Device Description… | 2015 |
| † | K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | 2018 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral… | 2020 | 1 |
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral… | 2022 | 0 |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital… | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2021 | Class II | Z-2385-2021 | Process control | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. |
| Jul 21, 2021 | Class II | Z-2386-2021 | Process control | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K203008 (Cardiovascular Systems, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K152694.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 system is a percutaneous orbital atherectomy system indicated as…
Read the full statement (152 words)
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 system is a
percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are
acceptable candidates for percutaneous transluminal angioplasty.
The Stealth 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 system 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/K190634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190634: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190634
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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