# K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console)

- Pathway: 510(k) (Special)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Sep 3, 2009 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: 11 generations back to K871011 (1987). 33 ancestors in all.
25 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)
- K091509: Jetstream G2 NXT System, Model PV20300, Pathway Medical Technologies, Inc. (2009) Summary page 1.
- K083837: Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) Summary page 1.
- K090325: Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) Summary page 1.
- K082186: Modification to Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 1.
- K083489: Jetstream Pathway PC Atherectomy System, Model OV10300, Pathway Medical Technologies, Inc. (2009) Summary page 1.
- K081328: Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K093456: Jetstream G3 System (2009), 24 descendants of its own
- 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

## Indications for use
The Jetstream G3TM 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/K092332
Methodology: https://510kreport.com/methodology