# P240006: VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)

- Pathway: PMA
- Applicant: Biosense Webster, Inc.
- Decided: Nov 6, 2024 after 231 days
- Product code: QZI (Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation)
- Device class: 3
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has 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
- Jan 5, 2025 · Class I · Z-1205-2025: Due to an observed trend of neurovascular events

Source page: https://510kreport.com/device/P240006
Methodology: https://510kreport.com/methodology