# 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

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Apr 10, 2013 after 30 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: 19 generations back to K871011 (1987). 43 ancestors in all.
5 later devices descend from it; 2 cite it directly.
3 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122916: Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 System, Medrad, Inc. (2012) Summary page 7.
- K120242: Jetstream Navitus L System, Pathway Medical Technologies, Inc. (2012) Summary page 7.
- K111229: Jetstream G3 (R) SF 1.6 System, Pathway Medical Technologies, Inc. (2011) Summary page 7.
- K110626: Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System, Pathway Medical Technologies, Inc. (2011) Summary page 7.
- 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 7.
- K101221: Jetstream G3 System, Model PV31300, PV Console, Model PVCN100, Pathway Medical Technologies, Inc. (2010) Summary page 7.
- K093456: Jetstream G3 System, Pathway Medical Technologies, Inc. (2009) Summary page 7.
- K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) Summary page 7.
- K091509: Jetstream G2 NXT System, Model PV20300, Pathway Medical Technologies, Inc. (2009) Summary page 7.
- K082186: Modification to Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 7.
- K081328: Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 7.

## Most influential descendants
- 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
- K211738: Rotarex Atherectomy System (2021), 1 descendant of its own
- K242757: Rotarex Atherectomy System (2025), 0 descendants of its own
- K181877: Phoenix 2.4mm Atherectomy Plus System (2018), 0 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/K130637
Methodology: https://510kreport.com/methodology