Cleared Traditional

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

K223050 · MicroVention, Inc. · Cardiovascular
Dec 2022
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K223050 is an FDA 510(k) clearance for the AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060), a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on December 21, 2022, 83 days after receiving the submission on September 29, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K223050 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date December 21, 2022
Days to Decision 83 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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