510(k) · Cleared
Recalled · Class II · 2017Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Aug 27, 2014 as substantially equivalent to K130637 (Medrad, Inc., 2013) after a 335-day review. Its family tree reaches back 20 generations to 1987. 3 of the 48 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2014
- Review
- 335 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 20 generations to K871011 (1987). 44 ancestors in all, the oldest K780551 (1978). 3 later devices descend from it, 1 citing it directly. 3 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 16 generations between
- 3 generations backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
- 2 generations backK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
- 1 generation backK130637 Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream…Medrad, Inc. · 2013
- This deviceK133023 Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85…Medrad, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK172315 Straub Endovascular SystemStraub Medical AG · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK211738 Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK242757 Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · Recalled (Class I)
Show all 20 generations
- Root · 20 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 19 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 18 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 17 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 16 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- 15 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 14 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- 13 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- 12 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 11 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 10 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
- 9 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
- 8 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
- 7 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
- 6 generations backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
- 5 generations backK101334 Jetstream G3 SE System, Jetstream G3 SF System Model PV31230…Pathway Medical Technologies, Inc. · 2010
- 4 generations backK111229 Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
- 3 generations backK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
- 2 generations backK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
- 1 generation backK130637 Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream…Medrad, Inc. · 2013
- This deviceK133023 Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85…Medrad, Inc. · 2014
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −19 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −18 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −17 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| −16 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| −15 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −14 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| −13 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| −12 | K083837 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −11 | K090325 | Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)… | Pathway Medical Technologies, Inc. | 2009 | — |
| −10 | K091509 | Jetstream G2 NXT System, Model PV20300 | Pathway Medical Technologies, Inc. | 2009 | — |
| −9 | K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).… | Pathway Medical Technologies, Inc. | 2009 | — |
| −8 | K093456 | Jetstream G3 System | Pathway Medical Technologies, Inc. | 2009 | — |
| −7 | K093918 | Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control… | Pathway Medical Technologies, Inc. | 2010 | — |
| −6 | K100462 | Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 | Pathway Medical Technologies, Inc. | 2010 | — |
| −5 | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE… | Pathway Medical Technologies, Inc. | 2010 | — |
| −4 | K111229 | Jetstream G3 (R) SF 1.6 System | Pathway Medical Technologies, Inc. | 2011 | — |
| −3 | K120242 | Jetstream Navitus L System | Pathway Medical Technologies, Inc. | 2012 | — |
| −2 | K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System… | Medrad, Inc. | 2012 | — |
| −1 | K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85… | Medrad, Inc. | 2013 | — |
| 0 (this device) | K133023 | Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6 | Medrad, Inc. | 2014 | — |
| +1 | K172315 | Straub Endovascular System | Straub Medical AG | 2018 | Class I |
| +2 | K211738 | Rotarex Atherectomy System | C.R. Bard, Inc. | 2021 | Class I |
| +3 | K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | 2025 | Class I |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 1 |
| 2021 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Summary page 7…510(k) JETSTREAM® XC 2.4/3.4 System JETSTREAM® XC 2.1/3.0 System K130637 JETSTREAM® SC 1.85 System JETSTREAM® SC 1.6 System However, the design rationale for and device testing of the… | 2013 |
| † | K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF… | 2012 |
| † | K120242 | Jetstream Navitus L System | 2012 |
| † | K111229 | Jetstream G3 (R) SF 1.6 System | 2011 |
| † | K110626 | Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L… | 2011 |
| † | K101334 | Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter… | 2010 |
| † | K101221 | Jetstream G3 System, Model PV31300, PV Console, Model PVCN100 | 2010 |
| † | K093456 | Jetstream G3 System | 2009 |
| † | K092332 | Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100… | 2009 |
| † | K091509 | Jetstream G2 NXT System, Model PV20300 | 2009 |
| † | K082186 | Modification to Pathway PV Atherectomy System | 2008 |
| † | K081328 | Pathway PV Atherectomy System | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172315 | Straub Endovascular System Class I | 2018 | 2 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2017 | Class II | Z-1922-2017 | Process control | Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled… |
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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 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 44 ancestors have a recall of any class.
- Of its descendants, K172315 (Straub Medical AG, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K130637.
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
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 the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133023: Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133023
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