# K082664: Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100

- Pathway: 510(k) (Special)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Oct 6, 2008 after 24 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: 7 generations back to K871011 (1987). 17 ancestors in all.
32 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)
- K081328: Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 1.
- K082186: Modification to Pathway PV Atherectomy System, Pathway Medical Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K083489: Jetstream Pathway PC Atherectomy System, Model OV10300 (2009), 28 descendants of its own
- K083837: Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) (2009), 28 descendants of its own
- K090325: Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) (2009), 27 descendants of its own
- K091509: Jetstream G2 NXT System, Model PV20300 (2009), 26 descendants of its own
- K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console) (2009), 25 descendants of its own

## Indications for use
The Pathway PV Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Source page: https://510kreport.com/device/K082664
Methodology: https://510kreport.com/methodology