510(k) · Cleared
Cleared2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Atheromed, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Jun 14, 2021 as substantially equivalent to K182972 (Volcano Atheromed, Inc., 2018) and 1 other predicate after a 28-day review. Its family tree reaches back 23 generations to 1987.
- Decided
- Jun 14, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K871011 (1987). 47 ancestors in all, the oldest K780551 (1978). No later device cites it as a predicate yet.
- Root · 23 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 19 generations between
- 3 generations backK143328 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix…Volcano Atheromed, Inc. · 2014
- 2 generations backK172386 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix…Volcano Atheromed, Inc. · 2017
- 1 generation backK182972 Phoenix Atherectomy SystemVolcano Atheromed, Inc. · 2018
- This deviceK211518 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm…Volcano Atheromed, Inc. · 2021
Show all 23 generations
- Root · 23 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 22 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 21 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 20 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 19 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- 18 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 17 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 16 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- 15 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 14 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 13 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
- 12 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 11 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
- 10 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
- 9 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
- 8 generations backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
- 7 generations backK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
- 6 generations backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
- 5 generations backK132682 Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking…Atheromed, Inc. · 2014
- 4 generations backK140944 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy…Atheromed, Inc. · 2014
- 3 generations backK143328 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix…Volcano Atheromed, Inc. · 2014
- 2 generations backK172386 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix…Volcano Atheromed, Inc. · 2017
- 1 generation backK182972 Phoenix Atherectomy SystemVolcano Atheromed, Inc. · 2018
- This deviceK211518 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm…Volcano Atheromed, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −22 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −21 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −20 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| −19 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| −18 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −17 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −16 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| −15 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −14 | K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −13 | K091509 | Jetstream G2 NXT System, Model PV20300 | Pathway Medical Technologies, Inc. | 2009 | — |
| −12 | K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).… | Pathway Medical Technologies, Inc. | 2009 | — |
| −11 | K093456 | Jetstream G3 System | Pathway Medical Technologies, Inc. | 2009 | — |
| −10 | K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control… | Pathway Medical Technologies, Inc. | 2010 | — |
| −9 | K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 | Pathway Medical Technologies, Inc. | 2010 | — |
| −8 | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE… | Pathway Medical Technologies, Inc. | 2010 | — |
| −7 | K111229 | Jetstream G3 (R) SF 1.6 System | Pathway Medical Technologies, Inc. | 2011 | — |
| −6 | K120242 | Jetstream Navitus L System | Pathway Medical Technologies, Inc. | 2012 | — |
| −5 | K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy… | Atheromed, Inc. | 2014 | — |
| −4 | K140944 | 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter… | Atheromed, Inc. | 2014 | — |
| −3 | K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix… | Volcano Atheromed, Inc. | 2014 | — |
| −2 | K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy… | Volcano Atheromed, Inc. | 2017 | — |
| −1 | K182972 | Phoenix Atherectomy System | Volcano Atheromed, Inc. | 2018 | — |
| 0 (this device) | K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix… | Volcano Atheromed, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K182972 | Phoenix Atherectomy SystemSummary page 4…diovascular Predicate Device: Trade Naine: Phoenix Atherectomy System 510(k) Numbers: K182972 and Kl 72386 Volcano Manufacturer: AtheroMed, Inc.… | 2018 |
| * | K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System… | 2017 |
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 34 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 6 of the 47 ancestors have a recall of any class.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not
intended for use in the coronary, carotid, iliac, or renal vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211518: 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211518
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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