Cleared Special

OBSIDIO? Conformable Embolic

K242507 · Boston Scientific · Cardiovascular
Oct 2024
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K242507 is an FDA 510(k) clearance for the OBSIDIO? Conformable Embolic, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on October 3, 2024, 42 days after receiving the submission on August 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K242507 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2024
Decision Date October 03, 2024
Days to Decision 42 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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