510(k) · Cleared
Recalled · Class II · 2017ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular System, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Jun 10, 2015 as substantially equivalent to K110389 (Cardiovascular Systems, Inc., 2011) and 4 other predicates after a 29-day review. Its family tree reaches back 12 generations to 1987. 1 of the 22 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 10, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 12 generations to K871011 (1987). 20 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 8 generations between
- 3 generations backK131092 Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013
- 2 generations backK133399 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · Recalled (Class I)
- 1 generation backK150732 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015
- This deviceK151260 ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital…Cardiovascular System, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK180416 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral…Cardiovascular Systems, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 11 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 10 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 9 generations backK071350 Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 8 generations backK072748 Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2007
- 7 generations backK081944 Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc. · 2008
- 6 generations backK090521 Diamondback 360 DBXCardiovascular Systems, Inc. · 2009 · Recalled
- 5 generations backK110389 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2011 · Recalled
- 4 generations backK122987 Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc. · 2012
- 3 generations backK131092 Stealth 360 Orbital Pad SystemCardio Systems, Inc. · 2013
- 2 generations backK133399 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · Recalled (Class I)
- 1 generation backK150732 Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2015
- This deviceK151260 ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital…Cardiovascular System, Inc. · 2015
Class I recalls in this family
- K133399 Diamondback 360 Peripheral Orbital Atherectomy…direct predicate · 2013
Most influential descendants
Showing 1 of 1 · See all- K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −11 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −10 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −9 | K071350 | Diamondback 360 Degree Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −8 | K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2007 | — |
| −7 | K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy System | Cardio Systems, Inc. | 2008 | — |
| −6 | K090521 | Diamondback 360 DBX | Cardiovascular Systems, Inc. | 2009 | 2 |
| −5 | K110389 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2011 | 1 |
| −4 | K122987 | Stealth 360 Orbital Pad System | Cardiovascular Systems, Inc. | 2012 | — |
| −3 | K131092 | Stealth 360 Orbital Pad System | Cardio Systems, Inc. | 2013 | — |
| −2 | K133399 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | 2013 | Class I |
| −1 | K150732 | Diamondback 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | 2015 | — |
| 0 (this device) | K151260 | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy… | Cardiovascular System, Inc. | 2015 | — |
| +1 | K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy… | Cardiovascular Systems, Inc. | 2018 | — |
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 |
|---|---|---|
| 2018 | 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? (5)
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 4…assification Regulation: 21 CFR 870.4875—Intraluminal Artery Stripper Classification: II Predicate Devices: 510(k) Numbers: K110389, K122987, K131092 Manufacturer: Cardiovascular Systems, Inc. Trade Name:… | 2011 |
| * | K122987 | Stealth 360 Orbital Pad SystemSummary page 4…ion Regulation: 21 CFR 870.4875—Intraluminal Artery Stripper Classification: II Predicate Devices: 510(k) Numbers: K110389, K122987, K131092 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Ste… | 2012 |
| * | K131092 | Stealth 360 Orbital Pad SystemSummary page 4…ation: 21 CFR 870.4875—Intraluminal Artery Stripper Classification: II Predicate Devices: 510(k) Numbers: K110389, K122987, K131092 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Stealth 360… | 2013 |
| * | K133399 | Diamondback 360 Peripheral Orbital Atherectomy SystemSummary page 4…anufacturer: Cardiovascular Systems, Inc. Trade Name: Stealth 360 Orbital PAD System 510(k) Number: K133399, K150732 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Dia… | 2013 |
| * | K150732 | Diamondback 360 Peripheral Orbital Atherectomy SystemSummary page 4…er: Cardiovascular Systems, Inc. Trade Name: Stealth 360 Orbital PAD System 510(k) Number: K133399, K150732 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Diamondback… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180416 | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)… | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2017 | Class II | Z-1771-2017 | Under Investigation by firm | Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip. |
| Feb 9, 2017 | Class II | Z-1877-2017 | Process control | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018 in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip. |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180416 (Cardiovascular Systems, Inc., 2018) has gone furthest, with 0 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 Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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/K151260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151260: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151260
Report an extraction error
Are you the manufacturer?
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