510(k) Report

510(k) · Cleared

Cleared

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

K220568510(k) TraditionalCleared Apr 27, 202258-day reviewClass II21 CFR 870.4875

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiovascualr Systems, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Apr 27, 2022 as substantially equivalent to K203008 (Cardiovascular Systems, Inc., 2020) after a 58-day review. Its family tree reaches back 11 generations to 1987.

Decided
Apr 27, 2022
Review
58 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
1

Its longest line of descent runs back 11 generations to K871011 (1987). 20 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2019: 1 other ancestor2005: 1 other ancestor1990: 1 other ancestor2007: 1 other ancestor1997: 2 other ancestors1988: 3 other ancestorsReference device: K090521 · Diamondback 360 DBX · Cardiovascular Systems, Inc. · 2009 · recalledK871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005×2: 2 generations cleared close together, K071350 (2007), K072748 (2007) K081944 · Modification to Diamondback 360 Degree Orbital Atherectomy System · Cardio Systems, Inc. · 2008K090521 · Diamondback 360 DBX · Cardiovascular Systems, Inc. · 2009 · recalledK110389 · Stealth 360 Orbital Pad System · Cardiovascular Systems, Inc. · 2011 · recalledK152694 · Diamondback 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · 2015 · recalledK182397 · Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series · Cardiovascular Systems, Inc. · 2018K203008 · DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · 20201990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor6 generations back: 2 other ancestors7 generations back: 3 other ancestors8 generations back: 3 other ancestors K203008 · DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · 2020K182397 · Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series · Cardiovascular Systems, Inc. · 2018K152694 · Diamondback 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · 2015 · recalledK110389 · Stealth 360 Orbital Pad System · Cardiovascular Systems, Inc. · 2011 · recalledK090521 · Diamondback 360 DBX · Cardiovascular Systems, Inc. · 2009 · recalledK081944 · Modification to Diamondback 360 Degree Orbital Atherectomy System · Cardio Systems, Inc. · 2008K072748 · Modification to: Diamondback 360 Orbital Atherectomy System · Cardiovascular Systems, Inc. · 2007K071350 · Diamondback 360 Degree Orbital Atherectomy System · Cardiovascular Systems, Inc. · 2007K043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987−10−50
  1. Root · 11 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 7 generations between
  3. 3 generations backK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
  4. 2 generations backK182397 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable…Cardiovascular Systems, Inc. · 2018
  5. 1 generation backK203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK…Cardiovascular Systems, Inc. · 2020
  6. This deviceK220568 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascualr Systems, Inc. · 2022
Show all 11 generations
  1. Root · 11 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 10 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 9 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 8 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
  5. 7 generations backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
  6. 6 generations backK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
  7. 5 generations backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
  8. 4 generations backK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
  9. 3 generations backK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
  10. 2 generations backK182397 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable…Cardiovascular Systems, Inc. · 2018
  11. 1 generation backK203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK…Cardiovascular Systems, Inc. · 2020
  12. This deviceK220568 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360…Cardiovascualr Systems, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−10K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−9K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−8K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.2007—
−7K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc.2007—
−6K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc.2008—
−5K090521Diamondback 360 DBXCardiovascular Systems, Inc.20092
−4K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.20111
−3K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20153
−2K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.2018—
−1K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360…Cardiovascular Systems, Inc.2020—
0 (this device)K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral…Cardiovascualr Systems, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198830
199010
199720
200510
200710
201910
FIG. 1 — Lineage of K220568, 1987–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…
Summary page 4
…ame: Intraluminal Artery Stripper Classification: Class II, 21 CFR 870.4875 Product Code: MCW Predicate Device(s): • Diamondback/Stealth = K203008 • Exchangeable = K203008 Reference Device • Predat…
Cardiovascular Systems, Inc.2020—
†K090521Diamondback 360 DBXCardiovascular Systems, Inc.20092

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 35 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
  • 6 of the 20 ancestors have a recall of any class.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MCW

3in 2025

2007: 52008: 62009: 82010: 62011: 62012: 52013: 52014: 72015: 62016: 52017: 72018: 82019: 32020: 22021: 62022: 62023: 42024: 32025: 32026 (partial year): 1
2007high 8 (2009) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCW

46in 2025

2007: 43 days median2008: 33 days median2009: 27 days median2010: 30 days median2011: 39 days median2012: 29 days median2013: 30 days median2014: 117 days median2015: 30 days median2016: 60 days median2017: 91 days median2018: 103 days median2019: 112 days median2021: 119 days median2022: 69 days median2023: 104 days median2024: 41 days median2025: 46 days median
2007high 119 (2021) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MCW

2in 2024

2007: 22008: 12009: 32010: 12016: 22017: 22021: 2, 2 Class I2022: 2, 2 Class I2023: 12024: 2
2007high 3 (2009) · low 0 (2011)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MCW

677in 2025

2007: 502008: 1152009: 1052010: 1672011: 2042012: 1942013: 1342014: 2102015: 3772016: 4092017: 4152018: 5372019: 6182020: 6312021: 7342022: 5662023: 5742024: 6772025: 677
2007high 734 (2021) · low 50 (2007)2025

MAUDE reports naming product code MCW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007543250
20086331115
20098273105
20106301167
20116390204
20125290194
20135300134
201471170210
20156300377
20165602409
20177912415
201881030537
201931120618
20202—0631
202161192 (2)734
20226692 (2)566
202341041574
20243412677
20253460677
20261—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 atherosclerosis disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS SOLID, CLASSIC and MICRO crowns support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital…

Read the full statement (308 words)

The Diamondback 360® Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for

use as therapy in patients with occlusive atherosclerosis disease in peripheral arteries and who are acceptable candidates for

percutaneous transluminal atherectomy.

The OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max

Crown has not been tested to support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).

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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max

Crown has not been tested to support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).

The Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series 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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max

Crown has not been tested to support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).

Indications for use as stated in the FDA summary.

Recent decisions in MCW

The MCW category page

  • K260244Auryon Atherectomy SystemEximo Medical · 2026
  • K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc., · 2025
  • K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics · 2025
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 20251 Class I recall
  • K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc., · 2024

https://510kreport.com/device/K220568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220568: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220568

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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