510(k) · Cleared
ClearedJetstream G3 (R) SF 1.6 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 Jun 1, 2011 as substantially equivalent to K101334 (Pathway Medical Technologies, Inc., 2010) and 1 other predicate after a 30-day review. Its family tree reaches back 16 generations to 1987. 3 of the 54 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Jun 1, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K871011 (1987). 38 ancestors in all, the oldest K780551 (1978). 15 later devices descend from it, 4 citing it directly. 3 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 12 generations between
- 3 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
- 2 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
- 1 generation backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
- This deviceK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
- Descendant · cites it directly · 14 of its ownK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK132682 Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking…Atheromed, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK140944 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy…Atheromed, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK130637 Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream…Medrad, Inc. · 2013
Show all 16 generations
- Root · 16 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 15 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 14 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 13 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 12 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- 11 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 10 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 9 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- 8 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 7 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 6 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
- 5 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 4 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
- 3 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
- 2 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
- 1 generation backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
- This deviceK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012 · cites it directly14descendants
- K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc. · 2014 · cites it directly6descendants
- K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc. · 2012 · cites it directly6descendants
- K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc. · 2014 · 2 generations on5descendants
- K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc. · 2013 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −15 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −14 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −13 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| −12 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| −11 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −10 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −9 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| −8 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −7 | K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −6 | K091509 | Jetstream G2 NXT System, Model PV20300 | Pathway Medical Technologies, Inc. | 2009 | — |
| −5 | K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).… | Pathway Medical Technologies, Inc. | 2009 | — |
| −4 | K093456 | Jetstream G3 System | Pathway Medical Technologies, Inc. | 2009 | — |
| −3 | K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control… | Pathway Medical Technologies, Inc. | 2010 | — |
| −2 | K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 | Pathway Medical Technologies, Inc. | 2010 | — |
| −1 | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE… | Pathway Medical Technologies, Inc. | 2010 | — |
| 0 (this device) | K111229 | Jetstream G3 (R) SF 1.6 System | Pathway Medical Technologies, Inc. | 2011 | — |
| +1 | K120242 | Jetstream Navitus L System | Pathway Medical Technologies, Inc. | 2012 | — |
| +1 | K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy… | Atheromed, Inc. | 2014 | — |
| +1 | K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System… | Medrad, Inc. | 2012 | — |
| +2 | K140944 | 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter… | Atheromed, Inc. | 2014 | — |
| +1 | K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85… | Medrad, Inc. | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 1 |
| 2021 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K101626 | FDA’s K101626 is Lensx Laser System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…Summary page 3…evices: Pathway Medical cites the following devices as substantially equivalent predicate devices: * Jetstream G3 SF System (Ki 10626) * Jetstream G3 SF System (K101334) * Pathway PVTM Atherectomy System (K08 1328) Testing Summary: To demonstrate substantial equivalence of the Jetstream G3 SF… | 2010 |
| * | K081328 | Pathway PV Atherectomy SystemSummary page 3…ces as substantially equivalent predicate devices: * Jetstream G3 SF System (Ki 10626) * Jetstream G3 SF System (K101334) * Pathway PVTM Atherectomy System (K08 1328) Testing Summary: To demonstrate substantial equivalence of the Jetstream G3 SF 1.6 System to the predicate device, the technolo… | 2008 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120242 | Jetstream Navitus L System | 2012 | 14 |
| K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter… | 2014 | 6 |
| K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF… | 2012 | 6 |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System… | 2013 | 5 |
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 24 years and passes through 4 companies; a new generation was cleared every 3 months on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K120242 (Pathway Medical Technologies, Inc., 2012) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K101334.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. 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/K111229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111229: Jetstream G3 (R) SF 1.6 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111229
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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