# K933238: Rotablator, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Heart Technology, Inc.
- Decided: Aug 24, 1993 after 70 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.
40 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K043465: 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 (2005), 25 descendants of its own
- K052296: Clirpath Turbo Excimer Laser Catheters (2005), 24 descendants of its own
- K052514: Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (2005), 23 descendants of its own
- K071227: Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, Model 310-154, 314-159, 317-15 (2007), 22 descendants of its own

Source page: https://510kreport.com/device/K933238
Methodology: https://510kreport.com/methodology