# K960379: Rotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire

- Pathway: 510(k) (Traditional)
- Applicant: Heart Technology Mfg., Inc.
- Decided: Apr 25, 1996 after 90 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Type C guide wire: named in the summary without a submission number

## Most influential descendants
- K121774: Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus (2012), 2 descendants of its own
- 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 Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.

Source page: https://510kreport.com/device/K960379
Methodology: https://510kreport.com/methodology