# K081328: Pathway PV Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Pathway Medical Technologies, Inc.
- Decided: Jul 17, 2008 after 66 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: 5 generations back to K871011 (1987). 15 ancestors in all.
34 later devices descend from it; 15 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)
- K024243: Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406, Fox Hollow Technologies (2003) Summary page 2.
- K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300, Fox Hollow Technologies (2005) Summary page 2.
- K053460: Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,, Fox Hollow Technologies (2006) Summary page 2.
- K061063: Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300, Foxhollow Technologies, Inc. (2006) Summary page 2.
- K061188: Silverhawk Peripheral Plaque Excision System, Foxhollow Technologies, Inc. (2006) Summary page 2.
- K901206: Rotablator, Heart Technology, Inc. (1990) Summary page 2.
- K954604: Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti Floppy, Heart Technology Mfg., Inc. (1996) Summary page 2.
- K970296: Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter, Boston Scientific Corp (1997) Summary page 2.
- K993648: Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter, Boston Scientific Corporation Northwest Technology (1999) Summary page 2.
- K890515: Peripheral Atherectomy System, Intensive Technology, Inc. (1989) Summary page 2.
- K922970: Intra-Operative Tec Atherectomy System, Intensive Technology, Inc. (1993) Summary page 2.

## Most influential descendants
- K082186: Modification to Pathway PV Atherectomy System (2008), 33 descendants of its own
- K082664: Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 (2008), 32 descendants of its own
- 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

## Indications for use
The Pathway PVTM 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/K081328
Methodology: https://510kreport.com/methodology