Cleared Traditional

Ruby XL System

K250079 · Penumbra, Inc. · Cardiovascular
Mar 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K250079 is an FDA 510(k) clearance for the Ruby XL System, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on March 14, 2025, 60 days after receiving the submission on January 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K250079 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2025
Decision Date March 14, 2025
Days to Decision 60 days
Submission Type Traditional
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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