510(k) · Cleared
ClearedPathway PV Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathway Medical Technologies, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Jul 17, 2008 as substantially equivalent to K024243 (Fox Hollow Technologies, 2003) and 10 other predicates after a 66-day review. Its family tree reaches back 5 generations to 1987. 3 of the 50 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it.
- Decided
- Jul 17, 2008
- Review
- 66 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 5 generations to K871011 (1987). 15 ancestors in all. 34 later devices descend from it, 15 citing it directly. 3 of the 50 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 4 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 3 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 2 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 1 generation backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- This deviceK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 33 of its ownK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 32 of its ownK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 28 of its ownK083489 Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 28 of its ownK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 27 of its ownK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
2008high 6 (2009) · low 0 (2020)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · cites it directly33descendants
- K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008 · cites it directly32descendants
- K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc. · 2009 · cites it directly28descendants
- K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc. · 2009 · 2 generations on28descendants
- K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc. · 2009 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −4 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −3 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −2 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| −1 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| 0 (this device) | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +1 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +1 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| +1 | K083489 | Jetstream Pathway PC Atherectomy System, Model OV10300 | Pathway Medical Technologies, Inc. | 2009 | — |
| +2 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| +2 | K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 1 |
| 2019 | 1 | 0 |
| 2021 | 4 | 1 |
| 2025 | 1 | 1 |
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.
3 devices in this family have 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? (11)
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…dicated for similar or identical use: * FoxHollow Technologies Inc. ReFORM Peripheral Catheter System (marketed as the SilverHawk® Plaque Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System -… | 2003 |
| * | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…Summary page 2…or similar or identical use: * FoxHollow Technologies Inc. ReFORM Peripheral Catheter System (marketed as the SilverHawk® Plaque Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K90120… | 2005 |
| * | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Summary page 2…r or identical use: * FoxHollow Technologies Inc. ReFORM Peripheral Catheter System (marketed as the SilverHawk® Plaque Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K95460… | 2006 |
| * | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Summary page 2…tical use: * FoxHollow Technologies Inc. ReFORM Peripheral Catheter System (marketed as the SilverHawk® Plaque Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K954604, K97029… | 2006 |
| * | K061188 | Silverhawk Peripheral Plaque Excision SystemSummary page 2…FoxHollow Technologies Inc. ReFORM Peripheral Catheter System (marketed as the SilverHawk® Plaque Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K954604, K970296, K993648 *… | 2006 |
| * | K901206 | RotablatorSummary page 2…wk® Plaque Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K954604, K970296, K993648 * InterVentional Technologies, Inc. Transluminal Endarterectomy Catheter (TEC) - K890515,… | 1990 |
| * | K954604 | Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti FloppySummary page 2…e Excision System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K954604, K970296, K993648 * InterVentional Technologies, Inc. Transluminal Endarterectomy Catheter (TEC) - K890515, K922970… | 1996 |
| * | K970296 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterSummary page 2…n System) - K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K954604, K970296, K993648 * InterVentional Technologies, Inc. Transluminal Endarterectomy Catheter (TEC) - K890515, K922970 Indicatio… | 1997 |
| * | K993648 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterSummary page 2…- K024243, K043553, K053460, K061063, K061188 · Boston Scientific Corporation Rotablator ® Rotational Angioplasty System - K901206, K954604, K970296, K993648 * InterVentional Technologies, Inc. Transluminal Endarterectomy Catheter (TEC) - K890515, K922970 Indications for Us… | 1999 |
| * | K890515 | Peripheral Atherectomy SystemSummary page 2…® Rotational Angioplasty System - K901206, K954604, K970296, K993648 * InterVentional Technologies, Inc. Transluminal Endarterectomy Catheter (TEC) - K890515, K922970 Indications for Use: The Pathway PV Atherectomy System is intended for use in atherectomy of the peripheral vasculature… | 1989 |
| * | K922970 | Intra-Operative Tec Atherectomy SystemSummary page 2…onal Angioplasty System - K901206, K954604, K970296, K993648 * InterVentional Technologies, Inc. Transluminal Endarterectomy Catheter (TEC) - K890515, K922970 Indications for Use: The Pathway PV Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is n… | 1993 |
What descends from it? (34)
See all 3415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082186 | Modification to Pathway PV Atherectomy System | 2008 | 33 |
| K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | 2008 | 32 |
| K083489 | Jetstream Pathway PC Atherectomy System, Model OV10300 | 2009 | 28 |
| K091509 | Jetstream G2 NXT System, Model PV20300 | 2009 | 26 |
| K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100… | 2009 | 25 |
| K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100… | 2010 | 23 |
| K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 | 2010 | 22 |
| K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter… | 2010 | 20 |
| K101221 | Jetstream G3 System, Model PV31300, PV Console, Model PVCN100 | 2010 | 19 |
| K111229 | Jetstream G3 (R) SF 1.6 System | 2011 | 15 |
Has anything in its family been recalled? (3 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K082186 (Pathway Medical Technologies, Inc., 2008) has gone furthest, with 33 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. 2008, 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 Pathway PVTM 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/K081328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081328: Pathway PV 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/K081328
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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