# K110626: Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System

- Pathway: 510(k) (Special)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Apr 20, 2011 after 47 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: 16 generations back to K871011 (1987). 39 ancestors in all.
10 later devices descend from it; 3 cite it directly.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101221: Jetstream G3 System, Model PV31300, PV Console, Model PVCN100, Pathway Medical Technologies, Inc. (2010) Summary page 3.
- 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.
- 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)

## Most influential descendants
- K122916: Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 System (2012), 6 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
- K133023: Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6 (2014), 3 descendants of its own
- K172315: Straub Endovascular System (2018), 2 descendants of its own
- K112308: Crosser Recanalization System (2011), 2 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/K110626
Methodology: https://510kreport.com/methodology