# K901206: Rotablator

- Pathway: 510(k) (Traditional)
- Applicant: Heart Technology, Inc.
- Decided: Sep 14, 1990 after 184 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.
102 later devices descend from it; 6 cite it directly.
4 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- 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
- K041630: Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2005), 30 descendants of its own

Source page: https://510kreport.com/device/K901206
Methodology: https://510kreport.com/methodology