# P990025: Navi-Star Diagnostic/Ablation Deflectable Tip Catheter

- Pathway: PMA
- Applicant: Biosense Webster, Inc.
- Decided: Jun 15, 2000 after 388 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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
- Oct 2, 2008 · Not classified · Z-0369-2010: Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter 

Source page: https://510kreport.com/device/P990025
Methodology: https://510kreport.com/methodology