# P960042: Spectranetics CVX-300 Excimer Laser System & Laser Sheath

- Pathway: PMA
- Applicant: Spectranetics (Philips)
- Decided: Dec 9, 1997 after 378 days
- Product code: MFA (Device, Removal, Pacemaker Electrode, Percutaneous)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 13, 2012 · Not classified · Z-1395-2012: Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
- Mar 16, 2009 · Not classified · Z-1264-2009: Catheter outer jacket may split during use.

Source page: https://510kreport.com/device/P960042
Methodology: https://510kreport.com/methodology