# K120242: Jetstream Navitus L System

- Pathway: 510(k) (Special)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Feb 24, 2012 after 28 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K871011 (1987). 40 ancestors in all.
14 later devices descend from it; 3 cite it directly.
3 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111229: Jetstream G3 (R) SF 1.6 System, Pathway Medical Technologies, Inc. (2011)
- K101334: Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod); PVCN100 (PV Con, Pathway Medical Technologies, Inc. (2010) Summary page 3.
- K101221: Jetstream G3 System, Model PV31300, PV Console, Model PVCN100, Pathway Medical Technologies, Inc. (2010) Summary page 3.
- K093456: Jetstream G3 System, Pathway Medical Technologies, Inc. (2009) Summary page 3.
- K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) Summary page 3.
- K100462: Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100, Pathway Medical Technologies, Inc. (2010) Summary page 3.
- K093918: Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2010) Summary page 3.
- K091509: Jetstream G2 NXT System, Model PV20300, Pathway Medical Technologies, Inc. (2009) Summary page 3.
- K082186: Modification to Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008)
- K081328: Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 3.

## Cited in the summary but kept off the family tree
- K110626: Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System, Pathway Medical Technologies, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132682: Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting Atherectomy CA (2014), 6 descendants of its own
- K122916: Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 System (2012), 6 descendants of its own
- K140944: 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (2014), 5 descendants of its own
- K130637: Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 System (2013), 5 descendants of its own
- K143328: 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (2014), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120242
Methodology: https://510kreport.com/methodology