Cleared Special

Prestige Coil System (Prestige Packing Line Extension)

K251383 · Balt USA, LLC · Cardiovascular
May 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251383 is an FDA 510(k) clearance for the Prestige Coil System (Prestige Packing Line Extension), a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on May 30, 2025, 28 days after receiving the submission on May 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K251383 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2025
Decision Date May 30, 2025
Days to Decision 28 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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