# K993648: Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation Northwest Technology
- Decided: Nov 24, 1999 after 26 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: 1 generation back to K970296 (1997). 1 ancestor in all.
38 later devices descend from it; 2 cite it directly.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970296: Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter, Boston Scientific Corp (1997) Summary page 1.

## 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 peripheral 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/K993648
Methodology: https://510kreport.com/methodology