# K133566: Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Dec 20, 2013 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: 3 generations back to K970296 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901206: Rotablator, Heart Technology, Inc. (1990) Summary page 1.
- K121774: Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus, Boston Scientific Corp (2012) Summary page 1.

## Most influential descendants
- K220962: ROTAPRO Rotational Atherectomy System (2022), 0 descendants of its own

## Indications for use
The Rotablator Rotational Atherectomy System is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.

Source page: https://510kreport.com/device/K133566
Methodology: https://510kreport.com/methodology