# K121774: Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 13, 2012 after 87 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: 2 generations back to K970296 (1997). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993648: Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter, Boston Scientific Corporation Northwest Technology (1999) Summary page 1.
- K960379: Rotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire, Heart Technology Mfg., Inc. (1996) Summary page 1.
- K933238: Rotablator, Modification, Heart Technology, Inc. (1993) Summary page 1.
- K913450: Heart Technology Rotablator Wireclip, Heart Technology, Inc. (1991) Summary page 1.

## Most influential descendants
- K133566: Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus (2013), 1 descendant of its own
- K220962: ROTAPRO Rotational Atherectomy System (2022), 0 descendants of its own

## Indications for use
The RotablatorTM 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/K121774
Methodology: https://510kreport.com/methodology