# P920047: Ept-1000 Cardiac Ablation System

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Oct 28, 1994 after 760 days
- Product code: LPB (Cardiac Ablation Percutaneous Catheter)
- Device class: 3
- Recalls of this device: 3 (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
- Jun 20, 2018 · Class II · Z-0202-2019: Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
- Jul 14, 2009 · Not classified · Z-0973-2011: Product malfunction causes inadvertent delivery of energy.
- Feb 14, 2008 · Not classified · Z-1617-2008: Package sterile barrier may be breached, compromising sterility.

Source page: https://510kreport.com/device/P920047
Methodology: https://510kreport.com/methodology