510(k) · Cleared
ClearedDiamondback 360 Degree 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 Aug 22, 2007 as substantially equivalent to K901206 (Heart Technology, Inc., 1990) and 2 other predicates after a 100-day review. Its family tree reaches back 3 generations to 1987. 1 of the 39 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it.
- Decided
- Aug 22, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K871011 (1987). 10 ancestors in all. 28 later devices descend from it, 6 citing it directly. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 2 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 1 generation backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- This deviceK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- Descendant · cites it directly · 26 of its ownK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- Descendant · cites it directly · 25 of its ownK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- Descendant · cites it directly · 20 of its ownK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 8 of its ownK152694 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…2 generations on · 2013
Most influential descendants
Showing 5 of 28 · See all- K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007 · cites it directly26descendants
- K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008 · cites it directly25descendants
- K090521Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · cites it directly24descendants
- K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · cites it directly20descendants
- K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −2 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −1 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| 0 (this device) | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| +1 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| +1 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| +1 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| +1 | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | 1 |
| +2 | K152694 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K901206 | RotablatorSummary page 1…ripheral Atherectomy Device Classification Name: 21 CER 870.4875, Peripheral Atherectomy Catheter Predicate Device: 5 10(k) Number: K90 1206 Manufacture: Heart Technologies (Acquired by Boston Scientific)… | 1990 |
| * | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…Summary page 1…by Boston Scientific) Trade Name: Rotablator Peripheral Atherectomy Device SI10(k) Number: K043553 Manufacture: Fox Hollow, hic. Trade Name: Silver H… | 2005 |
| * | K041630 | Orbital Atherectomy System for Treatment of a-V Shunt StenosisSummary page 1…Fox Hollow, hic. Trade Name: Silver Hawk Peripheral Plaque Excision System 5 10(k) Number: K041630 Manufacture: Cardiovascular Systems, Inc. Trade Name:… | 2005 |
What descends from it? (28)
See all 286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | 2007 | 26 |
| K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | 2008 | 25 |
| K090521 | Diamondback 360 DBX | 2009 | 24 |
| K110389 | Stealth 360 Orbital Pad System | 2011 | 20 |
| K111388 | Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System | 2011 | 0 |
| K072800 | Diamondback 360 Degree Orbital Atherectomy System | 2007 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K072748 (Cardiovascular Systems, Inc., 2007) has gone furthest, with 26 descendants of its own.
- 5 other devices also cite its predicate K901206.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 are who are acceptable candidates for percutaneous transluminal atherectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071350: Diamondback 360 Degree Orbital Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071350
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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