# K250310: VIKING™ Fixed Curve Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 27, 2025 after 144 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971265 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971265: Viking Diagnostic Electrode Catheter, C.R. Bard, Inc. (1997) Summary page 5.

## Indications for use
The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

Source page: https://510kreport.com/device/K250310
Methodology: https://510kreport.com/methodology