# K093456: Jetstream G3 System

- Pathway: 510(k) (Special)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Dec 1, 2009 after 26 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: 12 generations back to K871011 (1987). 34 ancestors in all.
24 later devices descend from it; 6 cite it directly.
3 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) Summary page 1.

## Most influential descendants
- K093918: Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (PV Console) (2010), 23 descendants of its own
- K100462: Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 (2010), 22 descendants of its own
- K101334: Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod); PVCN100 (PV Con (2010), 20 descendants of its own
- K101221: Jetstream G3 System, Model PV31300, PV Console, Model PVCN100 (2010), 19 descendants of its own
- K111229: Jetstream G3 (R) SF 1.6 System (2011), 15 descendants of its own

## Indications for use
The Jetstream G3™ 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 ≥ 3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Source page: https://510kreport.com/device/K093456
Methodology: https://510kreport.com/methodology