# K024243: Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406

- Pathway: 510(k) (Traditional)
- Applicant: Fox Hollow Technologies
- Decided: Jun 20, 2003 after 179 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871011 (1987). 4 ancestors in all.
116 later devices descend from it; 4 cite it directly.
6 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871011: Simpson Peripheral Atherocath (TM), Devices For Vascular Intervention, Inc. (1987) Summary page 1.
- K874706: Modified Simpson Peripheral Atherocath, Devices For Vascular Intervention, Inc. (1988) Summary page 1.
- K881088: Addition of a Tip Guard to the Atherocath (TM), Devices For Vascular Intervention, Inc. (1988) Summary page 1.
- K883346: Simpson Peripheral Atherocath W/Addit. Size 13F, Devices For Vascular Intervention, Inc. (1988) Summary page 1.

## Most influential descendants
- K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 (2005), 79 descendants of its own
- K053460: Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300, (2006), 52 descendants of its own
- K061188: Silverhawk Peripheral Plaque Excision System (2006), 50 descendants of its own
- K061063: Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300 (2006), 37 descendants of its own
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own

## Recalls of this device
- Jun 17, 2004 · Not classified · Z-1091-04: Devices for which sterility may be compromised.

## Indications for use
The ReFORM Peripheral Catheter System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

Source page: https://510kreport.com/device/K024243
Methodology: https://510kreport.com/methodology