# K101221: Jetstream G3 System, Model PV31300, PV Console, Model PVCN100

- Pathway: 510(k) (Special)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Jun 2, 2010 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: 15 generations back to K871011 (1987). 37 ancestors in all.
19 later devices descend from it; 3 cite it directly.
3 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100462: Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100, Pathway Medical Technologies, Inc. (2010). Cleared while this submission was under review Summary page 3.
- K093456: Jetstream G3 System, Pathway Medical Technologies, Inc. (2009) Summary page 2.
- K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) 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.
- K083837: Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console), Pathway Medical Technologies, Inc. (2009) Summary page 3.
- K081328: Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008). Our reading of the summary gave K051328, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pathway PVrhI Atherectomy System”.

## Most influential descendants
- K120242: Jetstream Navitus L System (2012), 14 descendants of its own
- K110626: Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System (2011), 10 descendants of its own
- 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

## 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/K101221
Methodology: https://510kreport.com/methodology