Cleared Special

OptiMap? System

K251344 · Boston Scientific Corporation · Cardiovascular
May 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251344 is an FDA 510(k) clearance for the OptiMap? System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Boston Scientific Corporation (St. Paul, US). The FDA issued a Cleared decision on May 28, 2025, 28 days after receiving the submission on April 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K251344 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2025
Decision Date May 28, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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