510(k) · Cleared
ClearedOrbital Atherectomy System for Treatment of a-V Shunt Stenosis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Systems Incorporated · MCW Catheter, Peripheral, Atherectomy
Cleared on Jan 31, 2005 as substantially equivalent to K970080 (Arrow Intl., Inc., 1997) and 2 other predicates after a 229-day review. Its family tree reaches back 1 generation to 1990. 1 of the 34 devices in its family, counting itself, has a Class I recall. 30 later devices descend from it.
- Decided
- Jan 31, 2005
- Review
- 229 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K901206 (1990). 3 ancestors in all. 30 later devices descend from it, 2 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK901206 RotablatorHeart Technology, Inc. · 1990
- This deviceK041630 Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated · 2005
- Descendant · cites it directly · 28 of its ownK071427 Diamondback 360 Degree Orbital Atherectomy System for Treatment of…Cardiovascular Systems, Inc. · 2007 · Recalled
- Descendant · cites it directly · 28 of its ownK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- Descendant · 2 generations on · 26 of its ownK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- Descendant · 2 generations on · 25 of its ownK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- Descendant · 2 generations on · 24 of its ownK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…3 generations on · 2013
Most influential descendants
Showing 5 of 30 · See all- K071427Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems, Inc. · 2007 · cites it directly28descendants
- K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007 · cites it directly28descendants
- K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007 · 2 generations on26descendants
- K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008 · 2 generations on25descendants
- K090521Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901206 | Rotablator | Heart Technology, Inc. | 1990 | — |
| 0 (this device) | K041630 | Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | Cardiovascular Systems Incorporated | 2005 | — |
| +1 | K071427 | Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt… | Cardiovascular Systems, Inc. | 2007 | 2 |
| +1 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| +2 | 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 | — |
| +2 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 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 |
|---|---|---|---|
| * | K970080 | Arrow-Trerotola PTD CatheterSummary page 1…l Atherectomy Device Classification Name: 21 CFR 870.4875, Peripheral Atherectomy Catheter Predicate Device: 510(k) Number: K970080 Manufacture: Arrow Trade Name: Arrow-T… | 1997 |
| * | K901206 | RotablatorSummary page 1…Manufacture: Arrow Trade Name: Arrow-Tremtola PTD 510(k) Number: K901206 Manufacture: Boston Scientific (Acquired from Heart Technology, Inc.)… | 1990 |
| * | K972357 | Blue Max - 20 Balloon Dilatation CatheterSummary page 1…Trade Name: Rotablator Orbital Atherectomy System - Peripheral Use 5 10(k) Number: K972357 Manufacture: Boston Scientific Frade Name-… | 1997 |
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041630: Orbital Atherectomy System for Treatment of a-V Shunt Stenosis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041630
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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