# P150005: Blazer Open-Irrigated Ablation Catheter

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Feb 24, 2016 after 387 days
- Product code: OAD (Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter)
- Device class: 3
- Recalls of this device: 1 (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
- Nov 28, 2018 · Class III · Z-0699-2019: Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s interna

Source page: https://510kreport.com/device/P150005
Methodology: https://510kreport.com/methodology