# K954604: Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti Floppy

- Pathway: 510(k) (Traditional)
- Applicant: Heart Technology Mfg., Inc.
- Decided: Jan 18, 1996 after 106 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.
35 later devices descend from it; 1 cites it directly.
3 of 36 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 A guide wires: named in the summary without a submission number
- (no number) Type C guide wires: named in the summary without a submission number

## Most influential descendants
- K081328: Pathway PV Atherectomy System (2008), 34 descendants of its own
- 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

## 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/K954604
Methodology: https://510kreport.com/methodology