510(k) · Cleared
ClearedPhoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting Atherectomy CA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atheromed, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Jan 17, 2014 as substantially equivalent to K024243 (Fox Hollow Technologies, 2003) and 9 other predicates after a 142-day review. Its family tree reaches back 18 generations to 1987. 6 later devices descend from it.
- Decided
- Jan 17, 2014
- Review
- 142 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 18 generations to K871011 (1987). 41 ancestors in all, the oldest K780551 (1978). 6 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 14 generations between
- 3 generations backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
- 2 generations backK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
- 1 generation backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
- This deviceK132682 Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking…Atheromed, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK140944 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy…Atheromed, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK143328 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix…Volcano Atheromed, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK172386 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix…Volcano Atheromed, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK151145 2.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK182972 Phoenix Atherectomy SystemVolcano Atheromed, Inc. · 2018
Show all 18 generations
- Root · 18 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 17 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 16 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 15 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 14 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- 13 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 12 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 11 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- 10 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 9 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 8 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
- 7 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 6 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
- 5 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
- 4 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
- 3 generations backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
- 2 generations backK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
- 1 generation backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
- This deviceK132682 Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking…Atheromed, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
2014high 2 (2014) · low 0 (2016)2026
Most influential descendants
Showing 5 of 6 · See all- K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc. · 2014 · cites it directly5descendants
- K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…Volcano Atheromed, Inc. · 2014 · 2 generations on3descendants
- K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc. · 2017 · 2 generations on2descendants
- K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc. · 2015 · cites it directly2descendants
- K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −17 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −16 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −15 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| −14 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| −13 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −12 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −11 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| −10 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −9 | K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −8 | K091509 | Jetstream G2 NXT System, Model PV20300 | Pathway Medical Technologies, Inc. | 2009 | — |
| −7 | K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).… | Pathway Medical Technologies, Inc. | 2009 | — |
| −6 | K093456 | Jetstream G3 System | Pathway Medical Technologies, Inc. | 2009 | — |
| −5 | K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control… | Pathway Medical Technologies, Inc. | 2010 | — |
| −4 | K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 | Pathway Medical Technologies, Inc. | 2010 | — |
| −3 | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE… | Pathway Medical Technologies, Inc. | 2010 | — |
| −2 | K111229 | Jetstream G3 (R) SF 1.6 System | Pathway Medical Technologies, Inc. | 2011 | — |
| −1 | K120242 | Jetstream Navitus L System | Pathway Medical Technologies, Inc. | 2012 | — |
| 0 (this device) | K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy… | Atheromed, Inc. | 2014 | — |
| +1 | K140944 | 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter… | Atheromed, Inc. | 2014 | — |
| +2 | 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 | K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | Volcano Atheromed, Inc. | 2015 | — |
| +2 | K182972 | Phoenix Atherectomy System | Volcano Atheromed, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (10)
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 |
|---|---|---|---|
| * | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter…Summary page 2…M Peripheral Plaque Excision System 5 10(k) Numbers: Multiple 5 10(k)s for the SilverHawk System family of devices, including K024243, K043553, K053460, K061063 and K061 188 (2) Device Trade Name: Pathway Medical Jetstreamn System 510(k) Numbers:… | 2003 |
| * | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…Summary page 2…ral Plaque Excision System 5 10(k) Numbers: Multiple 5 10(k)s for the SilverHawk System family of devices, including K024243, K043553, K053460, K061063 and K061 188 (2) Device Trade Name: Pathway Medical Jetstreamn System 510(k) Numbers: Multip… | 2005 |
| * | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Summary page 2…e Excision System 5 10(k) Numbers: Multiple 5 10(k)s for the SilverHawk System family of devices, including K024243, K043553, K053460, K061063 and K061 188 (2) Device Trade Name: Pathway Medical Jetstreamn System 510(k) Numbers: Multiple 5 10(k… | 2006 |
| * | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Summary page 2…n System 5 10(k) Numbers: Multiple 5 10(k)s for the SilverHawk System family of devices, including K024243, K043553, K053460, K061063 and K061 188 (2) Device Trade Name: Pathway Medical Jetstreamn System 510(k) Numbers: Multiple 5 10(k)s for th… | 2006 |
| * | K061188 | Silverhawk Peripheral Plaque Excision SystemSummary page 2…5 10(k) Numbers: Multiple 5 10(k)s for the SilverHawk System family of devices, including K024243, K043553, K053460, K061063 and K061 188 (2) Device Trade Name: Pathway Medical Jetstreamn System 510(k) Numbers: Multiple 5 10(k)s for the Jetstreamn… | 2006 |
| * | K081328 | Pathway PV Atherectomy SystemSummary page 2…: Pathway Medical Jetstreamn System 510(k) Numbers: Multiple 5 10(k)s for the Jetstreamn System family of devices, including K081328, K093918, K101334, KI 11229 and K120242 Device Description: The AtheroMed Phoenix Atherectomy System is a sterile, single-use d… | 2008 |
| * | K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…Summary page 2…Medical Jetstreamn System 510(k) Numbers: Multiple 5 10(k)s for the Jetstreamn System family of devices, including K081328, K093918, K101334, KI 11229 and K120242 Device Description: The AtheroMed Phoenix Atherectomy System is a sterile, single-use device des… | 2010 |
| * | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…Summary page 2…Jetstreamn System 510(k) Numbers: Multiple 5 10(k)s for the Jetstreamn System family of devices, including K081328, K093918, K101334, KI 11229 and K120242 Device Description: The AtheroMed Phoenix Atherectomy System is a sterile, single-use device designed for… | 2010 |
| * | K111229 | Jetstream G3 (R) SF 1.6 System | 2011 |
| * | K120242 | Jetstream Navitus L SystemSummary page 2…510(k) Numbers: Multiple 5 10(k)s for the Jetstreamn System family of devices, including K081328, K093918, K101334, KI 11229 and K120242 Device Description: The AtheroMed Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the pe… | 2012 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 6 of the 41 ancestors have a recall of any class.
- Of its descendants, K140944 (Atheromed, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K024243.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MCW
3in 2025
2007high 8 (2009) · low 2 (2020)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
2007high 119 (2021) · low 27 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
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
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
| 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. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132682: Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting Atherectomy CA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132682
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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