Cleared Traditional

Eclipse 2L

K183045 · Balt USA, LLC · Neurology
Apr 2019
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K183045 is an FDA 510(k) clearance for the Eclipse 2L, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on April 30, 2019, 179 days after receiving the submission on November 2, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K183045 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2018
Decision Date April 30, 2019
Days to Decision 179 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MJN — Catheter, Intravascular Occluding, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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