Cleared Traditional

VIKING? Fixed Curve Diagnostic Catheter

K250310 · Boston Scientific Corporation · Cardiovascular
Jun 2025
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K250310 is an FDA 510(k) clearance for the VIKING? Fixed Curve Diagnostic Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Boston Scientific Corporation (Alternate Contact, US). The FDA issued a Cleared decision on June 27, 2025, 144 days after receiving the submission on February 3, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K250310 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2025
Decision Date June 27, 2025
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

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